pulmicort and Respiratory-Distress-Syndrome--Newborn

To address the effectiveness and safety of early airway combined utilization of budesonide and surfactant for bronchopulmonary dysplasia (BPD) prevention in premature infants with respiratory distress syndrome (RDS).. Literature retrieval was carried out in the PubMed, Web of Science, EMBASE, Cochrane Library, Wanfang, CQ VIP, and China National Knowledge Infrastructure databases, searching from the inception to September 2021. Stata 16.0 software was used for statistical analysis.. This meta-analysis suggested that early combined utilization of budesonide and surfactant by airway have a superiority on BPD incidence (risk ratio [RR] = 0.62; 95% confidence interval [CI]: 0.54-0.71, p < 0.001], mortality (RR = 0.64; 95%CI: 0.45-0.92, p = 0.016), the composite outcome of BPD or mortality (RR = 0.58; 95%CI: 0.50-0.68, p < 0.001), the additional doses of surfactant (RR = 0.53; 95%CI: 0.44-0.63, p < 0.001), the duration of assisted ventilation (standard mean difference [SMD] = -1.14; 95%CI: -1.58 to -0.70, p < 0.001), duration of invasive ventilation(SMD = -1.77; 95% CI: -2.61 to -0.93, p < 0.001), and hospital stays (SMD = -1.11; 95% CI: -1.73 to -0.49, p = 0.001) in preterm infants with RDS. And these benefits were not associated with increased adverse outcomes. Furthermore, a decreased incidence of patent ducts arterious (PDA) (RR = 0.79; 95% CI: 0.65 to 0.97, p = 0.028) was found in premature infants treated with budesonide and surfactant. Subgroup analysis based on budesonide delivery methods (inhalation or intratracheal instillation) indicated that the decrease of mortality (RR = 0.63; 95% CI: 0.43-0.93, p = 0.019), duration of assisted ventilation (SMD = -0.95; 95% CI: -1.30 to -0.61, p < 0.001), hospital stays (SMD = -1.23; 95% CI: -2.05 to -0.41, p = 0.003) and PDA incidence (RR = 0.80; 95% CI: 0.65 to 0.99, p = 0.044) were mainly in budesonide intratracheal instillation subgroup, rather than in budesonide inhalation subgroup.. This meta-analysis suggested that early combined utilization of budesonide and surfactant by airway might be an effective and safe clinical practice for BPD prevention in premature infants with RDS, especially when budesonide was delivered by intratracheal instillation. However, many of the included studies were small and were from Asian origin. More well-designed randomized controlled trials with larger sample sizes and longer follow-up from all over the world ought to be conducted in the future.

Topics: Bronchopulmonary Dysplasia; Budesonide; Humans; Infant; Infant, Newborn; Infant, Premature; Respiratory Distress Syndrome, Newborn; Surface-Active Agents

Antenatal steroid treatment to enhance fetal lung maturity and surfactant treatment to prevent or treat respiratory distress syndrome have been major advances in perinatal medicine in the past 40 years contributing to improved outcomes for preterm infants. Use of postnatal steroids to prevent or treat chronic lung disease in preterm infants has been less successful and associated with adverse neurodevelopmental outcomes. Although early (in the first week of life) postnatal steroid treatment facilitates earlier extubation and reduces the risk of chronic lung disease, it is associated with adverse effects, such as hyperglycemia, hypertension, gastrointestinal bleeding and perforation, hypertrophic cardiomyopathy, growth failure, and cerebral palsy, and cannot be recommended. Early treatment with hydrocortisone may also improve survival without chronic lung disease, but concerns remain about possible adverse effects such as gastrointestinal perforation and sepsis, particularly in very preterm infants. Early inhaled budesonide also reduces the incidence of chronic lung disease but there are concerns that this may occur at the expense of increased risk of death. More studies of early low-dose steroids with adequate long-term follow-up are needed before they can be recommended for the prevention of chronic lung disease. Late (after the first week of life) postnatal steroids may have a better benefit-to-harm ratio than early steroids. A Cochrane Review shows that late steroid treatment reduces chronic lung disease, the combination of death and chronic lung disease at both 28 days and 36 weeks' corrected age, and the need for later rescue dexamethasone. Adverse effects include hyperglycemia, hypertension, hypertrophic cardiomyopathy, and severe retinopathy of prematurity but without an increase in blindness. Long-term neurodevelopmental effects are not significantly increased by late postnatal steroid treatment. Current recommendations are that postnatal steroid treatment should be reserved for preterm infants who are ventilator-dependent after the first 7-14 days of life and any course should be low dose and of short duration to facilitate endotracheal extubation. Budesonide/surfactant mixtures show some promise as a means of reducing chronic lung disease in preterm infants with severe respiratory distress syndrome, but further larger studies with long-term follow-up are needed before this treatment can be recommended as a routine intervention.

Topics: Anti-Inflammatory Agents; Budesonide; Chronic Disease; Dexamethasone; Drug Administration Schedule; Humans; Hydrocortisone; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Infant, Very Low Birth Weight; Randomized Controlled Trials as Topic; Respiratory Distress Syndrome, Newborn; Steroids

Despite the near universal adaptation of gentle mechanical ventilation, surfactant use and non-invasive respiratory support, bronchopulmonary dysplasia (BPD) remains one of the most common respiratory morbidities in very low birth weight (VLBW) infants. Thus, the objective of this review was to evaluate the efficacy of intra-tracheal administration of budesonide-surfactant mixture in preventing bronchopulmonary dysplasia (BPD) in very low birth weight (VLBW) infants. MEDLINE, EMBASE, and PubMed were searched for randomized clinical trials in which intra-tracheal administration of budesonide-surfactant was used to prevent BPD in infants. The primary outcomes were BPD and composite outcome of death or BPD. Meta-analysis of the two clinical trials revealed that infants who received intra-tracheal instillation of budesonide-surfactant mixture demonstrated 43% reduction in the risk of BPD (RR: 0.57; 95%CI: 0.43-0.76, NNT = 5). Although mortality was not different between the groups (OR: 0.61; 95%CI: 0.34-1.04), a 40% reduction was observed in the composite outcome of death or BPD in the budesonide-surfactant group (RR: 0.60; 95%CI: 0.49-0.74, NNT = 3). Thus, this review concludes that intra-tracheal administration of budesonide-surfactant combination was associated with decreased incidence of BPD alone or composite outcome of death or BPD in VLBW infants though there is a need for larger trials before it can be recommended as a standard of care.

Topics: Administration, Inhalation; Bronchopulmonary Dysplasia; Budesonide; Glucocorticoids; Humans; Infant, Newborn; Infant, Very Low Birth Weight; Pulmonary Surfactants; Randomized Controlled Trials as Topic; Respiration, Artificial; Respiratory Distress Syndrome, Newborn

Survival of extremely preterm infants has increased over recent years, but bronchopulmonary dysplasia (BPD) remains a major cause of morbidity. In the USA, BPD is the most common chronic respiratory disorder of infancy and affects the pulmonary and overall health of 10,000 preterm infants annually. Preclinical and clinical studies suggest a crucial role for lung inflammation and host immune response in the pathogenesis of BPD. Inflammation may result from, amongst others, chorioamnionitis, postnatal infection, ventilation, and the administration of oxygen. Infants with BPD have worse long-term outcomes than those without chronic lung disease. They are more than twice as likely to be readmitted to hospital in their first year of life and, having survived their primary hospitalizations, they are more likely to die than very preterm infants without chronic lung disease. Survivors with BPD have an increased risk of neurodevelopmental impairment and their respiratory function remains compromised well into adolescence. As the first generations of extremely low birth weight (ELBW) survivors have not yet reached retirement age, there are currently no reliable data addressing the association between BPD and pulmonary diseases of the elderly such as chronic obstructive pulmonary disease. Although BPD is quite common in ELBW infants, there are infants who do not develop BPD, which supports the argument that BPD is a preventable disease, emphasizing the need for high-quality safety and efficacy prevention studies. However, according to an Institute of Medicine statement regarding pediatric drug studies, the therapeutic area that has the fewest drugs indicated for neonates is BPD. As inflammation seems to be a primary mediator of injury in the pathogenesis of BPD, anti-inflammatory agents such as steroids have long been the focus of preventive research activities. However, systemic steroids, although reducing BPD, have frequently been linked to adverse neurodevelopmental outcomes and these considerations may have contributed to the recently reported widespread use of inhaled corticosteroids in neonatal units in North America and Europe. Inhaled corticosteroids were prescribed to 25% of infants born at <29 weeks of gestation with birth weights <1,500 g in neonatal units of 35 children's hospitals in the USA. According to a survey across all neonatal units in Germany, 46% administered inhaled corticosteroids to preterm infants either as prophylaxis or treatment for BPD

Topics: Administration, Inhalation; Bronchopulmonary Dysplasia; Budesonide; Europe; Germany; Gestational Age; Glucocorticoids; Humans; Infant; Infant, Newborn; Infant, Premature; Infant, Very Low Birth Weight; North America; Off-Label Use; Pulmonary Surfactants; Respiration, Artificial; Respiratory Distress Syndrome, Newborn; Steroids

A wide range of topics can be covered when considering a review of respiratory therapeutics. This review focuses on advances and controversies in the therapy of asthma, including issues regarding medications such as inhaled beta 2-agonists, inhaled corticosteroids, cromolyn sodium, and theophylline. Bronchodilator therapy for acute viral bronchiolitis remains a controversial issue and is discussed in light of recent published manuscripts. Issues regarding surfactant therapy for respiratory distress syndrome remain prominent in the neonatal respiratory therapeutics literature and recent findings in this area are reported. Advances in the treatment of cystic fibrosis, as well as a review concerning the pulmonary toxicity of various medications used in the treatment of pediatric illness are discussed.

Topics: Adrenal Cortex Hormones; Adrenergic beta-Agonists; Anti-Inflammatory Agents; Asthma; Bronchiolitis, Viral; Bronchodilator Agents; Budesonide; Child; Cystic Fibrosis; Hemosiderosis; Humans; Infant, Newborn; Lung Diseases; Methotrexate; Pregnenediones; Pulmonary Surfactants; Respiratory Distress Syndrome, Newborn; Theophylline

To study the efficacy and safety of early intratracheal administration of budesonide combined with pulmonary surfactant (PS) in preventing bronchopulmonary dysplasia (BPD).. A prospective randomized controlled trial was designed. A total of 122 infants with a high risk of BPD who were admitted to the neonatal intensive care unit of the Third Affiliated Hospital of Zhengzhou University from January to July 2021 were enrolled. The infants were randomly divided into a conventional treatment group with 62 infants (treated with PS alone at an initial dose of 200 mg/kg, followed by a dose of 100 mg/kg according to the condition of the infant) and an observation group with 60 infants (treated with PS at the same dose as the conventional treatment group, with the addition of budesonide 0.25 mg/kg for intratracheal instillation at each time of PS application). The two groups were compared in terms of the times of PS use, ventilator parameters at different time points, oxygen inhalation, incidence rate and severity of BPD, incidence rate of complications, and tidal breathing pulmonary function at the corrected gestational age of 40 weeks.. Compared with the conventional treatment group, the observation group had a significantly lower proportion of infants using PS for two or three times (. Compared with PS use alone in preterm infants with a high risk of BPD, budesonide combined with PS can reduce repeated use of PS, lower ventilator parameters, shorten the duration of respiratory support, and reduce the incidence rate and severity of BPD, without increasing the incidence rate of glucocorticoid-related complications.

Topics: Bronchopulmonary Dysplasia; Budesonide; Humans; Infant; Infant, Newborn; Infant, Premature; Prospective Studies; Pulmonary Surfactants; Respiration, Artificial; Respiratory Distress Syndrome, Newborn

Bronchopulmonary dysplasia (BPD) is an important complication of mechanical ventilation in preterm infants, and no definite therapy can eliminate this complication. Pulmonary inflammation plays a crucial role in its pathogenesis, and glucocorticoid is one potential therapy to prevent BPD.. To compare the effect of intratracheal administration of surfactant/budesonide with that of surfactant alone on the incidence of death or BPD.. A clinical trial was conducted in three tertiary neonatal centers in the United States and Taiwan, in which 265 very-low-birth-weight infants with severe respiratory distress syndrome who required mechanical ventilation and inspired oxygen (fraction of inspired oxygen, ≥50%) within 4 hours of birth were randomly assigned to one of two groups (131 intervention and 134 control). The intervention infants received surfactant (100 mg/kg) and budesonide (0.25 mg/kg), and the control infants received surfactant only (100 mg/kg), until each infant required inspired O2 at less than 30% or was extubated.. The intervention group had a significantly lower incidence of BPD or death (55 of 131 [42.0%] vs. 89 of 134 [66%]; risk ratio, 0.58; 95% confidence interval, 0.44-0.77; P < 0.001; number needed to treat, 4.1; 95% confidence interval, 2.8-7.8). The intervention group required significantly fewer doses of surfactant than did the control group. The intervention group had significantly lower interleukin levels (IL-1, IL-6, IL-8) in tracheal aspirates at 12 hours and lower IL-8 at 3-5 and 7-8 days.. In very-low-birth-weight infants with severe respiratory distress syndrome, intratracheal administration of surfactant/budesonide compared with surfactant alone significantly decreased the incidence of BPD or death without immediate adverse effect. Clinical trial registered with www.clinicaltrials.gov (NCT-00883532).

Topics: Bronchopulmonary Dysplasia; Budesonide; Drug Therapy, Combination; Female; Humans; Infant, Very Low Birth Weight; Intubation, Intratracheal; Male; Pulmonary Surfactants; Respiration, Artificial; Respiratory Distress Syndrome, Newborn

To study the efficacy of different preparations of budesonide combined with pulmonary surfactant (PS) in improving blood gas levels and preventing bronchopulmonary dysplasia (BPD) in preterm infants with neonatal respiratory distress syndrome (NRDS).. A total of 184 preterm infants who developed NRDS within 4 hours after birth were randomly administered with PS + continuous inhalation of budesonide aerosol (continuous aerosol group), PS+budesonide solution (solution group), PS + single inhalation of budesonide aerosol (single aerosol group), and PS alone, with 46 neonates in each group. The changes in arterial blood gas levels, rate of invasive mechanical ventilation after treatment, time of assisted ventilation, rate of repeated use of PS, and the incidence of BPD were compared between the four groups.. On the 2nd to 4th day after treatment, pH, PCO2, and oxygenation index (FiO2/PaO2) showed significant differences among the four groups, and the continuous aerosol group showed the most improvements of all indicators, followed by the solution group, single aerosol group, and PS alone group. The continuous aerosol group had a significantly shorter time of assisted ventilation than the other three groups (P<0.05). The solution group had a significantly shorter time of assisted ventilation than the single aerosol and PS alone groups (P<0.05). The rate of invasive mechanical ventilation after treatment, rate of repeated use of PS, and incidence of BPD showed significant differences among the four groups (P<0.05), and the continuous aerosol group had the lowest rates, followed by the solution group.. A combination of PS and continuous inhalation of budesonide aerosol has a better efficacy in the treatment of NRDS than a combination of PS and budesonide solution. The difference in reducing the incidence of BDP between the two administration methods awaits further investigation with a larger sample size.

Topics: Bronchopulmonary Dysplasia; Budesonide; Drug Therapy, Combination; Female; Humans; Infant, Newborn; Male; Pulmonary Surfactants; Respiration, Artificial; Respiratory Distress Syndrome, Newborn

Systemic glucocorticoids reduce the incidence of bronchopulmonary dysplasia among extremely preterm infants, but they may compromise brain development. The effects of inhaled glucocorticoids on outcomes in these infants are unclear.. We randomly assigned 863 infants (gestational age, 23 weeks 0 days to 27 weeks 6 days) to early (within 24 hours after birth) inhaled budesonide or placebo until they no longer required oxygen and positive-pressure support or until they reached a postmenstrual age of 32 weeks 0 days. The primary outcome was death or bronchopulmonary dysplasia, confirmed by means of standardized oxygen-saturation monitoring, at a postmenstrual age of 36 weeks.. A total of 175 of 437 infants assigned to budesonide for whom adequate data were available (40.0%), as compared with 194 of 419 infants assigned to placebo for whom adequate data were available (46.3%), died or had bronchopulmonary dysplasia (relative risk, stratified according to gestational age, 0.86; 95% confidence interval [CI], 0.75 to 1.00; P=0.05). The incidence of bronchopulmonary dysplasia was 27.8% in the budesonide group versus 38.0% in the placebo group (relative risk, stratified according to gestational age, 0.74; 95% CI, 0.60 to 0.91; P=0.004); death occurred in 16.9% and 13.6% of the patients, respectively (relative risk, stratified according to gestational age, 1.24; 95% CI, 0.91 to 1.69; P=0.17). The proportion of infants who required surgical closure of a patent ductus arteriosus was lower in the budesonide group than in the placebo group (relative risk, stratified according to gestational age, 0.55; 95% CI, 0.36 to 0.83; P=0.004), as was the proportion of infants who required reintubation (relative risk, stratified according to gestational age, 0.58; 95% CI, 0.35 to 0.96; P=0.03). Rates of other neonatal illnesses and adverse events were similar in the two groups.. Among extremely preterm infants, the incidence of bronchopulmonary dysplasia was lower among those who received early inhaled budesonide than among those who received placebo, but the advantage may have been gained at the expense of increased mortality. (Funded by the European Union and Chiesi Farmaceutici; ClinicalTrials.gov number, NCT01035190.).

Topics: Administration, Inhalation; Bronchopulmonary Dysplasia; Budesonide; Drug Administration Schedule; Ductus Arteriosus, Patent; Female; Fibrosis; Gestational Age; Glucocorticoids; Humans; Infant, Extremely Premature; Infant, Newborn; Infant, Premature, Diseases; Length of Stay; Lung; Male; Oxygen Inhalation Therapy; Positive-Pressure Respiration; Respiratory Distress Syndrome, Newborn

Budesonide is an inhaled steroid with a strong topical effect but with minimal systemic effects; it has been effectively delivered to animal lungs using surfactant as a vehicle. The purposes of this study were to determine whether early intratracheal instillation of budesonide using surfactant as a vehicle would improve pulmonary status, reduce mortality, and reduce chronic lung disease morbidity.. We conducted a prospective, randomized blind trial in 116 very low birth weight infants (< 1500 g) who had severe radiographic respiratory distress syndrome and required mechanical ventilation with fraction of inspired oxygen > or = 0.6 shortly after birth: 60 were in the treated group (intratracheal instillation of a mixture of 0.25 mg/kg of budesonide and 100.00 mg/kg of survanta, every 8 hours) and 56 were in the control group (100 mg/kg of survanta only, every 8 hours). The end point assessment was the number of infants who would die or develop chronic lung disease at 36 weeks' postconceptional age.. Infants in the treatment group required significantly lower mean airway pressure on day 1 and day 3 and had significantly lower oxygen index and PCO(2) during the first 3 days than infants in the control group. More infants were extubated in the treatment group than controls at 1 and 2 weeks. The combined outcome of deaths or chronic lung disease was significantly lower in the treatment group than in the control group (19 of 60 vs 34 of 56). No clinically significant adverse effects were observed during the study.. This pilot study indicated that early postnatal intratracheal instillation of budesonide using surfactant as vehicle significantly improved the combined outcome of death or chronic lung disease in small premature infants without causing immediate adverse effects. The results are encouraging, and a large sample multicenter trial is warranted.

Topics: Biological Products; Budesonide; Chronic Disease; Double-Blind Method; Female; Glucocorticoids; Humans; Infant, Newborn; Infant, Very Low Birth Weight; Instillation, Drug; Lung Diseases; Male; Pharmaceutical Vehicles; Prednisolone; Pulmonary Surfactants; Respiration, Artificial; Respiratory Distress Syndrome, Newborn; Survival Rate

Meconium aspiration syndrome (MAS) is one of the major causes of severe respiratory distress in the newborn and there is no uniform protocol of management after the development of MAS.. The objective of the study was to determine whether systemic and inhalational steroid therapy can alter the clinical course of MAS and improve the outcome without causing any serious adverse effects.. A randomized controlled trial was conducted in three groups of MAS over a period of 1 year. Group A (n = 33) served as controls, Group B (n = 34) received systemic methyl prednisolone and Group C (n = 32) received nebulized budesonide both for a period of 7 days starting after 24 h of age. Details of clinical progress were noted during the hospital stay. Follow up for a minimum period of 3 months was done in all. Data were analysed by SPSS 10 software. Student's t and ANOVA were used to assess statistical significance.. Patient profile was similar in all the three groups. Period of oxygen dependency and duration of hospital stay was significantly less in the steroid treated groups. Similarly full enteral feeding and radiological clearance of chest could be achieved earlier in groups B and C. No difference between the steroid treated groups could be appreciated by Student's Newman Kuel (SNK) test. Development of sepsis was similar in all the groups and no serious adverse effects were noted in steroid treated groups.. Steroids are effective in the management of MAS and route of administration does not have a bearing on the efficacy.

Topics: Administration, Inhalation; Analysis of Variance; Anti-Inflammatory Agents; Budesonide; Female; Humans; Infant, Newborn; Male; Meconium Aspiration Syndrome; Methylprednisolone; Pneumonia, Aspiration; Respiratory Distress Syndrome, Newborn

To compare early (<3 days) with late (>15 days) steroid therapy and dexamethasone with inhaled budesonide in very preterm infants at risk of developing chronic lung disease.. Five hundred seventy infants from 47 neonatal intensive care units were enrolled. Criteria for enrollment included gestational age <30 weeks, postnatal age <72 hours, and need for mechanical ventilation and inspired oxygen concentration >30%. Infants were randomly allocated to 1 of 4 treatment groups in a factorial design: early (<72 hours) dexamethasone, early budesonide, delayed selective (>15 days) dexamethasone, and delayed selective budesonide. Dexamethasone was given in a tapering course beginning with 0.50 mg/kg/day in 2 divided doses for 3 days reducing by half until 12 days of therapy had elapsed. Budesonide was administered by metered dose inhaler and a spacing chamber in a dose of 400 microg/kg twice daily for 12 days. Delayed selective treatment was started if infants needed mechanical ventilation and >30% oxygen for >15 days. The factorial design allowed 2 major comparisons: early versus late treatment and systemic dexamethasone versus inhaled budesonide. The primary outcome was death or oxygen dependency at 36 weeks and analysis was on an intention-to-treat basis. Secondary outcome measures included death or major cerebral abnormality, duration of oxygen treatment, and complications of prematurity. Adverse effects were also monitored daily.. There were no significant differences among the groups for the primary outcome. Early steroid treatment was associated with a lower primary outcome rate (odds ratio [OR]: 0.85; 95% confidence interval [CI]: 0.61,1.18) but even after adjustment for confounding variables the difference remained nonsignificant. Dexamethasone-treated infants also had a lower primary outcome rate (OR: 0.86; 95% CI: 0.62,1.20) but again this difference remained not significant after adjustment. For death before discharge, dexamethasone and early treatment had worse outcomes than budesonide and delayed selective treatment (OR: 1.42; 95% CI: 0.93,2.16; OR: 1.51; 95% CI: 0.99,2.30 after adjustment, respectively) with the results not quite reaching significance. Duration of supplementary oxygen was shorter in the early dexamethasone group (median: 31 days vs 40-44 days). Early dexamethasone was also associated with increased weight loss during the first 12 days of treatment (52 g vs 3 g) compared with early budesonide, but over 30 days there was no difference. In the early dexamethasone group, there was a reduced incidence of persistent ductus arteriosus (34% vs 52%-59%) and an increased risk of hyperglycemia (55% vs 29%-34%) compared with the other 3 groups. Dexamethasone was associated with an increased risk of hypertension and gastrointestinal problems compared with budesonide but only the former attained significance.. Infants given early treatment and dexamethasone therapy had improved survival without chronic lung disease at 36 weeks compared with those given delayed selective treatment and inhaled budesonide, respectively, but results for survival to discharge were in the opposite direction; however, none of these findings attained statistical significance. Early dexamethasone treatment reduced the risk of persistent ductus arteriosus. Inhaled budesonide may be safer than dexamethasone, but there is no clear evidence that it is more or less effective.

Topics: Administration, Inhalation; Bronchopulmonary Dysplasia; Budesonide; Cause of Death; Dexamethasone; Drug Administration Schedule; Factor Analysis, Statistical; Female; Glucocorticoids; Humans; Hyperglycemia; Hypertension; Infant, Newborn; Infant, Premature; Logistic Models; Male; Respiratory Distress Syndrome, Newborn

We investigated the effect of an aerosolized corticosteroid (budesonide) on the oxygen requirement of infants at high risk for developing chronic lung disease (CLD) in a randomized, double-blind study. The study objective was to attain a 30% decrease in FiO2 levels in the budesonide treatment group after 14 d of therapy. Thirty very low birthweight (VLBW) infants (median (range)) gestational age 26 wk (23-29) and birthweight 805 g (525-1227) were randomized. Inclusion criteria were mechanical ventilation on day 6 of life, or if extubated on nasal continuous positive airway pressure with FiO2 > or = 0.3. The budesonide (Pulmicort) dose was 500 microg bid, or placebo. The aerosol was delivered with a dosimetric jet nebulizer, with variable inspiratory time and breath sensitivity. Inhalations were started on day 7 of life. Twenty-seven patients completed the study. A significant lowering of the FiO2 levels at 21 d of life was not detected. Infants who received budesonide were more often extubated during the study period (7/8 vs 2/9) and had a greater relative change from baseline in their oxygenation index (budesonide decreased 26% vs placebo increased 60%). Subsequent use of intravenous dexamethasone or inhaled budesonide in the treatment group was significantly less. All patients required O2 supplementation on day 28 of life. At 36 wk postconceptual age, 61% of infants in the budesonide group needed supplemental O2 as opposed to 79% in the placebo group. No side effects on growth or adrenal function were observed.. We conclude that inhaled budesonide aerosol via dosimetric jet nebulizer started on day 7 of life for infants at high risk for developing CLD decreases the need for mechanical ventilation similar to intravenous dexamethasone, but without significant side effects.

Topics: Aerosols; Birth Weight; Bronchodilator Agents; Budesonide; Chronic Disease; Double-Blind Method; Female; Gestational Age; Humans; Hydrocortisone; Infant; Infant, Newborn; Infant, Very Low Birth Weight; Lung Diseases; Male; Respiration, Artificial; Respiratory Distress Syndrome, Newborn; Weight Gain

In order to assess the efficacy of a combination of systemic and nebulized corticosteroids in reducing the incidence and severity of chronic lung disease (CLD) in very low birthweight (VLBW) infants, 60 ventilator-dependent infants < or = 1500 g were randomly assigned to receive either steroids or placebo as of 7 d. The steroid group (n = 30, GA = 25.8 +/- 1.6 weeks, BW = 731 +/- 147 g) received systemic dexamethasone for 3 d, followed by nebulized budesonide for 18 d. Control infants (n = 30, GA = 25.9 +/- 1.8 weeks, BW = 796 +/- 199 g) received systemic and inhaled saline. Steroid-treated infants required less ventilatory support between 9 and 17 d (p < 0.01), and had greater lung compliance at 10 d (p = 0.01), but not subsequently. CLD incidence at 36 weeks was 45.5% vs 56.0% in controls, and fewer steroid-treated infants required dexamethasone rescue (23.3% vs 56.7%, p = 0.017). Survival to discharge was similar (73.3% vs 83.3%), as were the durations of mechanical ventilation, supplemental oxygen use, and hospitalization. Tracheal effluent elastase/albumin ratios and serum cortisol values did not differ between groups, and no adverse effects were noted. We conclude that early dexamethasone administration was associated with improved pulmonary function, which was not sustained with nebulized budesonide. However, the steroid regimen studied reduced the need for dexamethasone rescue in infants with CLD.

Topics: Administration, Inhalation; Budesonide; Dexamethasone; Double-Blind Method; Female; Glucocorticoids; Humans; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Infant, Very Low Birth Weight; Infusions, Intravenous; Male; Respiratory Distress Syndrome, Newborn; Respiratory Mechanics; Treatment Outcome

The combination of surfactant and budesonide has been shown to decrease BPD rates and severity. Budesonide may be released systemically from lungs, and the effects on the immature adrenal glands are not known.. The aim of this study was to determine if adrenal suppression rates are higher in preterm infants receiving budesonide with surfactant compared to surfactant alone.. A retrospective chart review of 608 infants ≤1,250 g received intubation for surfactant therapy from 2013 through 2020. In August 2016, budesonide was added to surfactant for these infants. Indicators of adrenal suppression, including mean blood pressures, plasma electrolyte levels, hydrocortisone use, and the use of vasoactive medications, were analyzed for the first 14 days after birth. Respiratory variables, biochemical signs of adrenal insufficiency, and neonatal morbidities were analyzed.. There was no difference in hydrocortisone administration in the first 14 days between infants receiving budesonide with surfactant (n = 314) or surfactant alone (n = 294) (23% vs. 19%, p = 0.38). Budesonide exposed infants received hydrocortisone 3 days later than surfactant only infants (median DOL 5 vs. 2, p < 0.001). Infants receiving budesonide had higher blood pressures, required less dopamine (19% vs. 39%, p < 0.001) and dobutamine (2% vs. 6%, p = 0.02). Budesonide exposed infants were discharged home after a shorter NICU stay (85 days vs. 94 days, p = 0.02) and at a younger gestational age (39 vs. 40 weeks, p = 0.001).. The use of surfactant and budesonide does not alter the rate of hydrocortisone use, but does delay the timing of treatment initiation and decreases the use of vasoactive medications.

Topics: Bronchopulmonary Dysplasia; Budesonide; Cohort Studies; Humans; Hydrocortisone; Infant; Infant, Newborn; Infant, Premature; Pulmonary Surfactants; Respiration, Artificial; Respiratory Distress Syndrome, Newborn; Respiratory System Agents; Retrospective Studies; Surface-Active Agents

To compare the efficacy of intra-tracheal (IT) surfactant/budesonide (SB) with that of surfactant alone (S) in reducing the rate of bronchopulmonary dysplasia (BPD) at 36 weeks post-menstrual age (PMA), we included extremely preterm very low birth weight (VLBW) infants with severe respiratory distress syndrome (RDS) in our tertiary neonatal level of care unit (Padua, Italy).. The preliminary results of this retrospective study suggest that in extremely preterm VLBW infants, IT SB for severe RDS did not affect the incidence of BPD, death, and BPD or death at 36 weeks PMA, compared to surfactant alone. The combined therapy proved to be safe in this population. Further studies are warranted to explore the role of early IT steroids on respiratory morbidity in preterm infants.

Topics: Bronchopulmonary Dysplasia; Budesonide; Child; Female; Humans; Infant; Infant, Extremely Premature; Infant, Newborn; Pregnancy; Respiration, Artificial; Respiratory Distress Syndrome, Newborn; Retrospective Studies; Surface-Active Agents

In preterm infants on moderately high ventilator support, the addition of budesonide to surfactant lowered bronchopulmonary dysplasia (BPD) rates by 20% without increased morbidity or mortality. The aim of this cohort comparison was to determine the safety and efficacy of the combination in infants with milder respiratory distress syndrome (RDS).. In August 2016 we began administering budesonide (0.25 mg/kg) mixed with surfactant (Survanta 4 mL/kg) to all infants ≤ 1250 g who failed CPAP and required intubation. Infants were compared to a historical cohort (2013-2016) who received surfactant alone.. BPD or death did not change between the historical surfactant cohort (71%, n = 294) and the budesonide cohort (69%, n = 173). Budesonide was associated with a decrease in the need for continued mechanical ventilation, severe BPD type II or death (19-12%), grade III BPD or death (31-21%), and the median gestational age at discharge was 1 week earlier. Histologic chorioamnionitis was associated with decreased budesonide effects. Secondary morbidities (NEC, IVH, ROP, Sepsis) were similar.. Overall BPD rates remained unchanged with the addition of budesonide. Budesonide was associated with decreased severity of BPD, decreased mechanical ventilation use, earlier discharge, and similar short-term outcomes.

Topics: Bronchopulmonary Dysplasia; Budesonide; Chorioamnionitis; Female; Humans; Infant, Newborn; Male; Patient Discharge; Patient Safety; Pregnancy; Pulmonary Surfactants; Respiration, Artificial; Respiratory Distress Syndrome, Newborn; Surface-Active Agents; Treatment Outcome

Respiratory distress syndrome (RDS) is a major cause of early postnatal death in preterm infants. Bronchopulmonary dysplasia (BPD) is one of the most fatal chronic respiratory complications of preterm infants after management of RDS. Anti-inflammatory therapy with corticosteroid is one of the effective treatments to prevent BPD. However, systemic administration of corticosteroid is not recommended because of long-term adverse effects. We studied the effect of early intratracheal instillation of budesonide with surfactant in preterm infants with severe RDS.. Very low birth weight infants (VLBWIs) weighing less than 1,500 g who were admitted to the neonatal intensive care unit (NICU) of Busan Paik Hospital between January 2018 and December 2018 and diagnosed with severe RDS were enrolled. The treatment group was given a mixture of budesonide and surfactant (calfactant) while the control group was given surfactant (calfactant) only.. Surfactant re-dosing, duration of mechanical ventilation, BPD, mortality, and retinopathy of prematurity (≥ stage 2) were not different between the two groups though there were decreasing trends in the treatment group compared to those in the control group. The duration of hospital stay was longer in the control group with statistical significance.. Early intratracheal administration of budesonide with surfactant in preterm infants with severe RDS might decrease BPD and mortality without disturbing surfactant function. Further studies with different preparations of surfactants with a large number of preterm infants are required.

Topics: Bronchopulmonary Dysplasia; Budesonide; Humans; Infant, Newborn; Infant, Premature; Infant, Very Low Birth Weight; Respiration, Artificial; Respiratory Distress Syndrome, Newborn; Surface-Active Agents

Topics: Bronchopulmonary Dysplasia; Budesonide; Humans; Infant, Newborn; Pulmonary Surfactants; Respiratory Distress Syndrome, Newborn; Surface-Active Agents

Topics: Bronchopulmonary Dysplasia; Budesonide; Glucocorticoids; Humans; Infant, Newborn; Respiratory Distress Syndrome, Newborn

Data on inhaler technique and its effects on maternal and fetal outcomes during pregnancy are seldom reported. The primary objective of this study was to evaluate inhaler technique and identify errors in inhaler use among pregnant women with asthma. Secondary objectives were to identify factors associated with poor inhaler technique and study the association between inhaler technique and maternal and fetal outcomes. This was a cross-sectional, face-to-face, prospective study of 80 pregnant women with physician-diagnosed asthma. Seventy-three and 41 asthmatic pregnant women reported using pressurized metered dose inhalers (pMDIs) and dry powder inhalers (DPIs), respectively. Overall, wrong inhaler technique was observed in 47 (64.4%) subjects. Among pMDI users, correct inhaler use was observed in only 26/73 (35.6%) of the patients, with lack of coordination between inhalation and generation of the aerosol and failure to breathe out gently before using the inhaler, being the most common errors. Among DPI users, 21 (51.2%) demonstrated correct inhaler use, with failure to perform a breath-hold for 10 seconds after inhaling the powder and to exhale gently before using the inhaler being the most common errors. Significant associations between inhaler technique and patient's understanding of asthma medications and the kind of follow-up clinic (respiratory versus nonrespiratory clinic) were found. No significant associations between inhaler technique and various maternal and fetal outcomes or asthma control were found. In conclusion, improper inhalation technique is significantly prevalent in pregnant asthmatic women, particularly among those being followed in nonspecialized respiratory clinics. The lack of significant association between the inhaler technique and asthma control (and hence maternal and fetal outcomes) may simply reflect the high prevalence of uncontrolled asthma and significant contribution of other barriers to poor asthma control in the current patient's cohort. Multidisciplinary management of asthma during pregnancy with particular emphasis on patient's education is imperative.

Topics: Administration, Inhalation; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Cesarean Section; Congenital Abnormalities; Cross-Sectional Studies; Disease Progression; Dry Powder Inhalers; Female; Fluticasone-Salmeterol Drug Combination; Humans; Infant, Low Birth Weight; Infant, Newborn; Metered Dose Inhalers; Patient Medication Knowledge; Pregnancy; Pregnancy Complications; Prospective Studies; Qatar; Respiratory Distress Syndrome, Newborn

BackgroundThe intratracheal (IT) administration of budesonide using surfactant as a vehicle has been shown to reduce the incidence of bronchopulmonary dysplasia (BPD) in preterm infants. The objective of this study was to characterize the in vitro characteristics and in vivo safety and efficacy of the extemporaneous combination of budesonide and poractant alfa.MethodsThe stability, minimum surface tension, and viscosity of the preparation were evaluated by means of high-performance liquid chromatography (HPLC), Wilhelmy balance, and Rheometer, respectively. The safety and efficacy of the IT administration of the mixture were tested in two respiratory distress syndrome (RDS) animal models: twenty-seventh day gestational age premature rabbits and surfactant-depleted adult rabbits.ResultsA pre-formulation trial identified a suitable procedure to ensure the homogeneity and stability of the formulation. Wilhelmy Balance tests clarified that budesonide supplementation has no detrimental effect on poractant alfa surface tension activity. The addition of budesonide to poractant alfa did not affect the physiological response to surfactant treatment in both RDS animal models, and was associated to a significant reduction of lung inflammation in surfactant-depleted rabbits.ConclusionOur in vitro and in vivo analysis suggests that the IT administration of a characterized extemporaneous combination of poractant alfa and budesonide is a safe and efficacious procedure in the context of RDS.

Topics: Animals; Biological Products; Bronchoalveolar Lavage Fluid; Bronchodilator Agents; Bronchopulmonary Dysplasia; Budesonide; Disease Models, Animal; Drug Administration Routes; Female; In Vitro Techniques; Phospholipids; Pregnancy; Pulmonary Surfactants; Rabbits; Respiratory Distress Syndrome, Newborn; Surface Tension; Trachea; Viscosity

Topics: Administration, Inhalation; Bronchopulmonary Dysplasia; Budesonide; Humans; Infant; Infant, Extremely Premature; Infant, Newborn; Infant, Premature; Respiratory Distress Syndrome, Newborn

To explore the clinical efficacy of intratracheal instillation of pulmonary surfactant (PS) combined with budesonide for preventing bronchopulmonary dysplasia (BPD) in very low birth weight (VLBW) infants.. Thirty VLBW infants with gestational age <32 weeks who developed neonatal respiratory distress syndrome (NRDS) (grade III-IV) suffering from intrauterine infection were randomly assigned into a PS + budesonide group and a PS alone group. The changes were compared between the two groups in arterial blood gas indexes, oxygenation index (OI), duration of mechanical ventilation, duration of oxygen supplementation, incidence of BPD, mortality rate at 36 weeks corrected gestational age and incidences of other complications except BPD.. Compared with the PS alone group, the PS+budesonide group had a lower incidence of BPD, shorter duration of mechanical ventilation and oxygen supplementation (P<0.05). On the 2nd to 6th day after treatment, the PS+budesonide group had higher pH value of arterial blood gas and OI and lower carbon dioxide partial pressure compared with the PS alone group (P<0.05). There were no significant differences in the mortality rate at 36 weeks corrected gestational age and the incidences of other complications except BPD between the two groups (P>0.05).. Intratracheal instillation of PS combined with budesonide can effectively reduce the incidence of BPD in VLBW premature infants with severe NRDS.

Topics: Bronchopulmonary Dysplasia; Budesonide; Female; Humans; Infant, Newborn; Infant, Very Low Birth Weight; Male; Pulmonary Surfactants; Respiration, Artificial; Respiratory Distress Syndrome, Newborn

Topics: Bronchopulmonary Dysplasia; Budesonide; Humans; Infant, Newborn; Pulmonary Surfactants; Respiratory Distress Syndrome, Newborn

Topics: Bronchopulmonary Dysplasia; Budesonide; Humans; Infant, Newborn; Pulmonary Surfactants; Respiratory Distress Syndrome, Newborn; Surface-Active Agents

Pulmonary surfactant provides an alveolar surface-active film that is critical for normal lung function. Our objective was to determine in vitro film formation properties of therapeutic and infant surfactants and the influence of surfactant protein (SP)-B content.. We used a multiwell fluorescent assay measuring maximum phospholipid surface accumulation (Max), phospholipid concentration required for half-maximal film formation (½Max), and time for maximal accumulation (tMax).. Among five therapeutic surfactants, calfactant (highest SP-B content) had film formation values similar to natural surfactant, and addition of SP-B to beractant (lowest SP-B) normalized its Max value. Addition of budesonide to calfactant did not adversely affect film formation. In tracheal aspirates of preterm infants with evolving chronic lung disease, SP-B content correlated with ½Max and tMax values, and SP-B supplementation of SP-B-deficient infant surfactant restored normal film formation. Reconstitution of normal surfactant indicated a role for both SP-B and SP-C in film formation.. Film formation in vitro differs among therapeutic surfactants and is highly dependent on SP-B content in infant surfactant. The results support a critical role of SP-B for promoting surface film formation.

Topics: Biological Products; Budesonide; Fluorescence; Humans; In Vitro Techniques; Infant, Newborn; Phospholipids; Pulmonary Surfactant-Associated Protein B; Pulmonary Surfactants; Respiratory Distress Syndrome, Newborn

Severe respiratory distress syndrome (RDS) is still a major cause of mortality and morbidity in premature infants. The combined use of intratracheal corticosteroid and surfactant in severe RDS, which bypasses the systemic circulation, may not only help recruit the lungs but also alleviates pulmonary inflammation without an increase in systemic adverse effects. Twelve newborn piglets received repeated pulmonary saline lavage to create surfactant-depleted lungs that mimic neonatal RDS, and then were randomly grouped into a control group (standard intratracheal instillation of surfactant-Survanta 100 mg/kg); and a budesonide (Bude) group (intratracheal instillation with the mixed suspension of Budesonide 0.25 mg/kg and Survanta 100 mg/kg). Blood samples were examined, and the observation period was 24 hr. The results showed that oxygenation was significantly better in Bude group compared to the control group over time (P = 0.016). The proinflammatory cytokines tumor necrosis factor-α and interleukin-1 β showed a reduced trend in the Bude group, but was not significantly different from the control group (P > 0.05). Comparing the histological lung injury scores, the Bude group had a significantly lower score than the control group at both dependent and non-dependent sites (P < 0.05). In conclusion, in piglets with severe RDS, intratracheal instillation of budesonide in addition to surfactant seems to results in a sustained improvement in pulmonary outcome over 24 hr.

Topics: Administration, Topical; Animals; Animals, Newborn; Anti-Inflammatory Agents; Budesonide; Drug Therapy, Combination; Humans; Infant, Newborn; Interleukin-1beta; Lung Compliance; Lung Injury; Male; Oximetry; Pulmonary Surfactants; Random Allocation; Respiratory Distress Syndrome, Newborn; Swine; Trachea; Tumor Necrosis Factor-alpha

Chronic lung disease continues to be a major complication in premature infants with severe respiratory distress syndrome (RDS). This is despite having advanced ventilatory care, prenatal corticosteroids, and postnatal surfactant therapies. The combined use of intratracheal corticosteroids and surfactant may not only recruit the lungs, but also alleviate pulmonary inflammation in severe RDS.. Fifteen newborn piglets received repeated pulmonary saline lavage to induce surfactant-depleted lungs, mimicking neonatal RDS. They were randomly divided into three groups: control group receiving no treatment; surfactant (Surf) group, treated with standard intratracheally instilled surfactant (100 mg/kg); and Budesonide plus surfactant (Bude + Surf) group, treated with intratracheally administered mixed suspension of budesonide (0.5 mg/kg) and surfactant (100 mg/kg). Blood samples were taken every 30 minutes for 4 hours. Lung tissue was examined after the experiment.. Significantly better oxygenation with higher PaO(2) and alveolar-arterial oxygen difference was noted in the Surf and Bude + Surf groups, compared with the control group (p < 0.05), but there were no significant differences between the Surf and Bude + Surf groups. Pulmonary histologic damage was also markedly alleviated in both the Surf and Bude + Surf groups, compared with the control group, and lung injury scores were significantly decreased in the Surf and Bude + Surf groups, compared with the control group (p < 0.05).. Intratracheal instillation of surfactant or surfactant plus budesonide can improve oxygenation and pulmonary histologic outcome in neonatal surfactant-depleted lungs. The additional use of budesonide does not disturb the function of the exogenous surfactant. Intratracheal administration of a corticosteroid combined with surfactant may be an effective method for alleviating local pulmonary inflammation in severe RDS.

Topics: Animals; Animals, Newborn; Budesonide; Disease Models, Animal; Glucocorticoids; Humans; Infant, Newborn; Instillation, Drug; Pulmonary Surfactants; Respiratory Distress Syndrome, Newborn; Swine; Trachea

In 1999, 80% of French neonatal centers used corticosteroids, mainly betamethasone (BMT), to prevent or treat bronchopulmonary dysplasia (BPD) [Lee SK, McMillan DD, Ohlson A, et al. Variations in practice and outcomes in the canadian NICU Network 1996-1997. Pediatrics 2000;106:1070-9]. As many data suggested a low risk-benefit ratio, an updated assessment of this use was necessary [Desnoulez L, Empana J, Anceschi M, et al. Prise en charge de l'immaturité pulmonaire en néonatologie : enquête sur les pratiques européennes. Arch Pediatr 2005;12:4-9; Halliday HL, Ehrenkranz RA, Doyle LW. Early postnatal (less than 96h) corticosteroids for preventing chronic lung disease in preterm infants. Cochrane Database Syst Rev 2003:CD001146; Yeh TF, Lin YJ, Lin HC, et al. Outcomes at school age after postnatal dexamethasone therapy for lung disease of prematurity. N Engl J Med 2004;350:1304-13; Lin YJ, LKin CH, Wu JM, et al. The effects of early postnatal dexamethasone therapy on pulmonary outcome in premature infants with respiratory distress syndrome: a 2-year follow-up study. Acta Paediatr 2005;94:310-16].. Questionnaires addressing the use of and indications for corticosteroids were sent to all French neonatal centers.. The study was conducted over 5 months (July to November 2006). Of 202 questionnaires sent out, 186 (92%) were completed. Of these 186 centers, 147 (79%) had a standard protocol for corticosteroid use, covering systemic and inhaled steroids (76 units), only systemic steroid therapy (30 units) and only inhaled steroids (41 units). Systemic corticosteroids were used in 106 centers for hemodynamic purposes in 42 cases (40%), prevention of BPD in 1 case (1%), early treatment of BPD (day 4 to day 21) in 23 cases (22%) and late treatment of BPD (after day 21) in 74 cases (70%). Hemisuccinate hydrocortisone (HSHC) was the only corticoid used for hemodynamic failure. The steroid used for early treatment of BPD was BMT (21 out of 23). The duration of treatment was less than 4 days in 10 centers (43%). The steroid most often used for late treatment was BMT (67 out of 74). The duration of treatment was less than 4 days in 29 centers, between 4 and 8 days in 22 centers, and longer than 8 days in 26 centers. Among 117 centers administering corticosteroids by inhalation, 74% used budesonide. Use of corticosteroids was higher in teaching hospitals (86%) than in others (49%), likely due to the immaturity of the neonates hospitalized in these centers.. We showed a still frequent use of corticosteroids in preterm infants in France but only after the fourth day of life to treat BPD and not as a prevention therapy. We also found a marginal use of DXM in accordance with both short-term and long-term adverse side effects, suggesting an unbalanced risk-benefit ratio even though it has a beneficial effect on respiratory status. Our findings indicate the need for national recommendations and trials to assess oral BMT treatment in premature neonates with BPD.

Topics: Administration, Inhalation; Anti-Inflammatory Agents; Betamethasone; Bronchopulmonary Dysplasia; Budesonide; Dexamethasone; Drug Administration Schedule; Drug Utilization; Female; Follow-Up Studies; France; Gestational Age; Glucocorticoids; Hemodynamics; Humans; Hydrocortisone; Infant, Low Birth Weight; Infant, Newborn; Infusions, Intravenous; Male; Prednisolone; Respiratory Distress Syndrome, Newborn; Risk Assessment; Surveys and Questionnaires

We investigated the role of eosinophils in the pathogenesis of bronchopulmonary dysplasia (BPD) in preterm infants.. Fifteen preterm infants with BPD were compared to 13 preterms with respiratory distress syndrome (RDS) and to 16 healthy preterms. We assessed total eosinophil and neutrophil counts in venous blood samples and the levels of the eosinophilic activity markers eosinophilic cationic protein (ECP) and the cellular surface antigen (CD9).. The eosinophil count was greater in BPD compared with RDS and healthy infants (1414 vs. 797 and 471 cells per microlitre, respectively, p = 0.03). ECP levels were elevated (34 vs. 12.8 and 9.8 microg/L, respectively, p = 0.002) and CD9 levels reduced (75 vs. 94 and 86 mean fluorescence intensity units, respectively, p = 0.01) in BPD compared with RDS and healthy infants, suggesting eosinophilic activation in BPD. These findings were not solely explained by differences between gestational age or birth weight of the different groups. ECP levels were positively correlated with the duration of oxygen supplementation in the BPD group. The eosinophil count fell promptly after steroid treatment was commenced in the BPD group.. The findings suggest that BPD is linked to eosinophil activation, which might contribute to the pathogenesis.

Topics: Antigens, CD; Biomarkers; Bronchodilator Agents; Bronchopulmonary Dysplasia; Budesonide; Eosinophil Cationic Protein; Eosinophil Granule Proteins; Eosinophils; Female; Flow Cytometry; Fluorescent Antibody Technique, Direct; Humans; Infant; Infant, Newborn; Infant, Premature; Male; Membrane Glycoproteins; Respiratory Distress Syndrome, Newborn; Severity of Illness Index; Tetraspanin 29

The aim of this pilot study was to determine the effect of early inhaled budesonide on clinical and inflammatory parameters in preterm infants ventilated for respiratory distress syndrome.. Neither the inflammatory process associated with respiratory distress syndrome nor the progression to bronchopulmonary dysplasia appeared to be altered by treatment with inhaled budesonide.

Topics: Bronchodilator Agents; Bronchopulmonary Dysplasia; Budesonide; Humans; Infant, Newborn; Infant, Premature; Inflammation; Longitudinal Studies; Respiratory Distress Syndrome, Newborn; Treatment Failure

Acute reversible airways obstruction in children, especially those aged under one year, who may respond poorly to inhaled beta 2-stimulants, is difficult to treat in general practice. In an open study, 48 episodes in 29 children, half aged under one year, were treated with budesonide (Pulmicort) 0.1-2.09 mg used to charge a Nebuhaler fitted with a facemask. In 45 instances, clinical improvement was observed, and with doses of 0.8 mg and above, this usually occurred within 10 minutes. This study suggests that budesonide via a suitable delivery system can evoke rapid improvement in reversible airways obstruction in young children.

Topics: Administration, Inhalation; Airway Obstruction; Asthma; Budesonide; Child; Child, Preschool; Humans; Infant; Infant, Newborn; Masks; Pregnenediones; Respiratory Distress Syndrome, Newborn