cardiovascular-agents and Birth-Weight

Extremely preterm infants are peculiar in regard to their risk of retinopathy of prematurity (ROP). In this study, we aim to study insults that may affect extremely preterm infants, including prenatal, at birth, and postnatal insults and their effect on the development of ROP.. This study used the data from Prematurity and Respiratory Outcomes Program (PROP). All included infants with a gestational age of 23 0/7 to 28 6/7 weeks using best obstetrical estimate. We included stressful events and/or modifiable variables that may affect the normal development. We used multiple regression analysis in our statistical analysis.. We included a total of 751 infants in our study. The mean birth weight for the included sample was 915.1 (±232.94) grams. 391 (52.1%) Infants were diagnosed with ROP. We found a significant negative correlation between ROP development and birth weight (p < 0.001), with a correlation coefficient of - 0.374. We found that the need for prophylactic indomethacin (OR 1.67), the occurrence of air leaks (OR: 2.35), ventilator-associated pneumonia (OR: 2.01), isolated bowel perforations (OR: 3.7), blood culture-proven sepsis (OR: 1.5), other infections (OR: 1.44), and receiving ventricular shunt (OR: 2.9) are significantly associated with the development of ROP.. We believe this study included the largest number of factors studied in the largest sample of extremely premature infants. We recommend a screening program for extremely preterm infants that takes into account a scoring system with higher scores for complicated condition.

Topics: Birth Weight; Cardiovascular Agents; Cellulitis; Cerebrospinal Fluid Shunts; Continuous Positive Airway Pressure; Ductus Arteriosus, Patent; Embolism, Air; Female; Humans; Indomethacin; Infant, Extremely Low Birth Weight; Infant, Extremely Premature; Infant, Newborn; Infant, Very Low Birth Weight; Intestinal Perforation; Male; Mediastinal Emphysema; Meningitis; Neonatal Sepsis; Pneumonia, Ventilator-Associated; Pneumopericardium; Pneumoperitoneum; Pneumothorax; Protective Factors; Retinopathy of Prematurity; Subcutaneous Emphysema; Urinary Tract Infections

We, herein, report the first use of a Magmaris® magnesium-based vascular scaffold for native aortic coarctation in a 1,980 g infant with multiple malformations. Due to the low body weight, complex illness, and clinical instability, it was decided to delay surgical correction. After insufficient results had been obtained by balloon angioplasty, Magmaris® implantation was chosen to bridge the patient to surgery by stabilizing left ventricular function and to allow for sufficient growth. Due to significant early stent restenosis and complete loss of radial force, the patient required balloon reangioplasty only 21 days after Magmaris® implantation and early surgical correction. In addition, high systemic sirolimus levels were detected 48 hr after the intervention (5 ng/mL). Although the bioresorbable scaffold was successfully used as a short-term bridge-to-surgery in our case, due to significant early stent failure (loss of radial force), this approach does not seem promising for long-term bridging of infants with aortic coarctation. In addition, the consequences of sirolimus-induced systemic immunosuppression may further limit the applicability of Magmaris® scaffolds in infants with congenital heart disease.

Topics: Absorbable Implants; Aortic Coarctation; Birth Weight; Cardiovascular Agents; Endovascular Procedures; Female; Humans; Infant, Low Birth Weight; Infant, Newborn; Magnesium; Prosthesis Design; Prosthesis Failure; Recurrence; Retreatment; Sirolimus; Stents; Treatment Outcome

Indomethacin is the most frequently used pharmacological agent for closure of a patent ductus arteriosus (PDA) in premature infants. However, reports of complications, particularly, necrotizing enterocolitis (NEC) and isolated gastrointestinal perforation have generated concerns about the use of this medication.. A retrospective study to compare the incidence of NEC, NEC-related gastrointestinal complications and isolated gastrointestinal perforation among premature infants treated for a PDA with either, indomethacin alone (I), surgical ligation alone (L), or indomethacin followed by surgical ligation (I-L).. The medical records of 224 infants that underwent treatment, either pharmacological or surgical, for a PDA, confirmed by echocardiography, over a 4-year period (1995 to 1998) were analyzed. Treatment history and gastrointestinal complications were reviewed.. Of the 224 infants, 108 (48.2%) were treated with I, 50 (22.3%) by L, 66 (29.5%) with I-L. The clinical characteristics of the three treatment groups were similar and no differences in the incidence of NEC were observed between groups. NEC occurred in 14 (13%) of the I group, seven (14%) of the L group, and eight (12%) of the I-L group. The rate of NEC related gastrointestinal complications and isolated gastrointestinal perforation were also similar among groups.. In this large retrospective study, indomethacin treatment for a significant PDA in premature infants was not associated with a greater risk for NEC or NEC-related gastrointestinal complications than surgical ligation.

Topics: Birth Weight; Cardiac Surgical Procedures; Cardiovascular Agents; Ductus Arteriosus, Patent; Enterocolitis, Necrotizing; Gastrointestinal Diseases; Gestational Age; Humans; Indomethacin; Infant, Newborn; Infant, Premature; Intestinal Perforation; Ligation; Retrospective Studies

Patent ductus arteriosus (PDA) is a frequent complication in premature infants. Intravenous indomethacin is the standard mode of medical therapy and has been shown to be efficacious in closing the ductus. In our setup, oral indomethacin is being regularly used for medical treatment of suspected or clinically diagnosed PDA. Non-availability of the parenteral preparation and lack of information regarding the pharmacokinetic disposition of indomethacin in the premature infants in north Indian population led us to conduct this pharmacokinetic study with oral indomethacin.. Twenty premature infants with gestational age 30.3 +/- 0.3 wk and birth weight, 1209.8 +/- 39.5 g; admitted to the neonatal unit of the Nehru Hospital, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh were enrolled in the study. Indomethacin was administered in a single oral dose of 0.2 mg/kg and blood samples were collected through an indwelling vascular catheter at 0 and 1, 2, 4, 8 and 12 h after administration of indomethacin. Plasma indomethacin concentrations were assayed by spectrofluorometric technique.. Large interindividual variability was observed for peak plasma concentrations (Cmax; 137.9 +/- 14.0 ng/ml), elimination half-life (t1/2 el; 21.4 +/- 1.7 h) and area under the plasma concentrations time curve (AUC0-infinity;4172 +/- 303 ng.h/ml) in these infants. Variables like birth weight, and sex did not have any sigiificant effect on indomethacin pharmacokinetics. However, the plasma t1/2 el of indomethacin was significantly (P < 0.01) larger in older infants (gestational age > 30 wk) in comparison to younger ones (gestational age < or = 30 wk). There was a negative correlation between gestational age and elimination t1/2 (r = -0.77).. In conclusion, indomethacin pharmacokinetics showed a wide variability in premature infants. In view of these findings it can be suggested that infants of smaller gestational age are at greater risk of cumulative toxicity if more than one dose of indomethacin is given. With advancing age, metabolism as well as elimination of drug is faster that may require modification in indomethacin dose to achieve therapeutic response. These preliminary results may be of use in designing future pharmacokinetic studies of oral indomethacin in preterm neonates on a larger sample.

Topics: Administration, Oral; Birth Weight; Cardiovascular Agents; Ductus Arteriosus, Patent; Female; Humans; India; Indomethacin; Infant, Newborn; Infant, Premature; Male

To determine patent ductus arteriosus (PDA) closure rates, and indomethacin (INDO) toxicity rates in neonates dosed with INDO using an individualized pharmacokinetic/pharmacodynamic (PK/PD) dosing approach. In addition, develop PD curves evaluating dose-response and concentration-response relationships for closure and renal toxicity, especially in select subgroups historically known as "poor responders" (<1000 g and > or = 10 days postnatal age).. Prospective, cohort study.. Level III neonatal intensive care unit.. One hundred thirty-nine patients receiving 151 courses of INDO for PDA closure were evaluated.. Patients initially received 0.25 mg/kg of INDO, followed immediately by 1 mg/kg of furosemide. INDO concentrations were obtained 2 hrs and 8 hrs after the dose and were assayed using high-performance liquid chromatography. Individualized PK parameters were calculated with subsequent INDO dosing based on the individualized PK variables to increase trough serum concentrations by 0.3-0.5 mg/L.. Ductal closure was successful in 127 patients (91%). Renal toxicity occurred in 21 (15%) patients and was temporary and reversible. No significant differences in response rates based on treatment weight or postnatal age were observed. PD curves were similar for neonates <1000 g vs. > or = 1000 g. PD curves were also similar for neonates with postnatal age <10 days vs. > or = 10 days. Statistically significant differences were noted between neonates categorized for postnatal age <10 days vs. > or = 10 days in total days of therapy (1.8 vs. 2.3 days), total number of doses required to close PDA (3.5 vs. 5.6 doses), critical INDO dose (0.9 vs. 1.4 mg/kg), critical INDO concentration (1.9 vs. 1.4 mg/L), and critical dose/critical concentration ratio (0.52 vs. 2.2).. These findings support the hypothesis that the poor PDA closure rates with INDO for neonates >10 days postnatal age are the result of pharmacokinetic differences only and that weight does not impact response rates. Individualized pharmacokinetic/pharmacodynamic dosing of INDO continues to achieve higher closure rate than current dosing standards. Patients historically known as poor responders significantly benefit from this dosing approach.

Topics: Age Factors; Algorithms; Birth Weight; Cardiovascular Agents; Dose-Response Relationship, Drug; Ductus Arteriosus, Patent; Gestational Age; Humans; Indomethacin; Infant, Newborn; Prospective Studies; Reference Values; Treatment Outcome