ro13-9904 and Infant--Newborn--Diseases

To compare the efficacy of ceftriaxone before skin incision and after cord clamping in preventing post-operative infectious morbidity and neonatal outcome in elective caesarean section and to determine the effect of antibiotic prophylaxis before skin incision on neonatal outcome.. Our study was a randomised controlled trial conducted among 874 women undergoing elective caesarean section from October 2010 to July 2012. These women were randomly categorised into two groups with 437 women in each group. Group 1 received single dose of ceftriaxone 1 g intravenously 15-45 min before skin incision. Group 2 received the antibiotic after cord clamping. Primary outcome measures were maternal post-operative infectious morbidities like surgical site wound infection, febrile morbidity, endometritis, urinary tract infections and neonatal sepsis. Results were analysed using Chi-square test and unpaired t test.. Surgical site wound infection occurred in 3 women in group 1 (0.7%) and 6 women in group 2 (1.4%). Fever occurred in 9 women in group 1 (2.1%) and 5 in group 2 (1.1%) with the p value of 0.419, not statistically significant. Urinary tract infection occurred in 9 women in group 1 (2.1%) and 7 women in group 2 (1.6%) with the p value of 0.801. None of the women in either group developed endometritis. About 20 neonates [10 neonates (2.3%) in group 1 and 10 neonates (2.3%) in group 2] required NICU admission after caesarean delivery. The reasons for admission were respiratory distress, prematurity and congenital anomaly. About 0.9% of neonates in group 1 and 1.8% in group 2 developed neonatal sepsis with positive blood culture (p = 0.388).. Timing of administration of prophylactic antibiotics for elective caesarean section either before skin incision or after cord clamping did not have significant difference in the occurrence of post-operative infectious morbidity. No adverse neonatal outcome was observed in women who received the antibiotic before skin incision.

Topics: Adult; Anti-Bacterial Agents; Antibiotic Prophylaxis; Ceftriaxone; Cesarean Section; Drug Administration Schedule; Endometritis; Female; Fever; Humans; Infant, Newborn; Infant, Newborn, Diseases; Morbidity; Perioperative Care; Postoperative Complications; Pregnancy; Sepsis; Surgical Wound Infection; Time Factors; Treatment Outcome; Urinary Tract Infections

Cesarean delivery is associated with a significantly higher postoperative infection rate than that following vaginal birth and other surgical procedures. This study compared whether antibiotic prophylaxis administered preoperatively was more effective in preventing infectious morbidity following cesarean delivery than administration at cord clamping.. In a randomized comparative trial, 953 women with a period of gestation of more than 34 weeks, scheduled to have cesarean section, were randomly assigned to the prophylactic single-dose antibiotic administration either preoperatively (study group) or at cord clamping (control group). Primary outcome measure was postoperative maternal infectious morbidity and secondary outcome measures were neonatal complications, and postoperative maternal hospital stay and stay of neonates in the neonatal intensive care unit.. Wound complications in the form of indurations, erythema and discharge, were significantly fewer in the study group as compared to the control group (10/476 vs 25/477, P = 0.010, conditional maximum likelihood estimate of odds ratio = 0.388 and 95% confidence interval = 0.175-0.805). Women in the study group also had fewer incidents of endomyometritis when compared to the control group (1.47% vs 3.56%; P = 0.041; conditional maximum likelihood estimate of odds ratio = 0.404). There was no significant difference in neonatal outcomes between the two groups. Mean postoperative stay of mothers in hospital was significantly shorter in the study group (P = 0.009, 95% confidence interval = -0.368 to -0.052) but neonatal intensive care unit stay of neonates was similar in both groups.. Administration of prophylactic antibiotic at 30-60 min before skin incision resulted in better maternal outcome when infectious morbidity and postoperative hospital stay were concerned, without influencing the neonatal outcome.

Topics: Adult; Anti-Bacterial Agents; Antibiotic Prophylaxis; Ceftriaxone; Cesarean Section; Double-Blind Method; Humans; Incidence; India; Infant, Newborn; Infant, Newborn, Diseases; Prospective Studies; Sepsis; Surgical Wound Infection; Young Adult

Cefotaxime has been used for the management of neonatal infections since the 1990s for suspected meningitis and to mitigate gentamicin-associated renal injury. Its shortage in 2015 and subsequent removal from the U.S. pharmaceutical market forced providers to consider alternatives. Ceftriaxone, a cephalosporin with an identical antibacterial spectrum of activity to cefotaxime, is contraindicated in neonates due to its risk of biliary pseudolithiasis. Ceftazidime was recommended as an alternative by the American Academy of Pediatrics but is inequivalent.. This article addresses indications for cephalosporin use and considerations when selecting an alternative to cefotaxime. Differences among cefotaxime, ceftriaxone, ceftazidime, and cefepime are discussed and compared to the standard-of-care presumptive regimen, ampicillin, and gentamicin. The authors consider the data behind the neonatal contraindication to ceftriaxone and provide recommendations for their application to practice.. The data against ceftriaxone use in neonates remain poor, particularly in the context of the cefotaxime shortage and lack of an equivalent alternative. Ceftriaxone could be considered in low-risk neonates without hyperbilirubinemia or exposure to calcium-containing fluids on a case-by-case basis. Ceftazidime monotherapy for presumptive management of neonatal infections is inappropriate; cefepime should be more frequently utilized in neonates who are poor candidates for ceftriaxone.

Topics: Ampicillin; Anti-Bacterial Agents; Calcium; Cefepime; Cefotaxime; Ceftazidime; Ceftriaxone; Cephalosporins; Communicable Diseases; Gentamicins; Humans; Infant, Newborn; Infant, Newborn, Diseases; Microbial Sensitivity Tests

To describe a term newborn with acquired severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and multisystem involvement including seizures associated to ischemic lesions in the brain.. Coronavirus disease 2019 (COVID-19) is predominantly a respiratory infection, but it may affect many other systems. Most pediatric COVID-19 cases range from asymptomatic to mild-moderate disease. There are no specific clinical signs described for neonatal COVID-19 infections. In children, severe central nervous system compromise has been rarely reported.. We describe a 17-day-old newborn who acquired a SARS-CoV-2 infection in a family meeting that was admitted for fever, seizures and lethargy and in whom consumption coagulopathy, ischemic lesions in the brain and cardiac involvement were documented.. SARS-CoV-2 neonatal infection can be associated with multi-organic involvement. In our patient, significant central nervous system compromise associated to ischemic lesions and laboratory findings of consumption coagulopathy were found.. Although neonatal SARS-CoV-2 infections are infrequent, they can be associated with multi-organic involvement. Neonatologists and pediatricians should be aware of this unusual way of presentation of COVID-19 in newborn infants.

Topics: Acyclovir; Anti-Bacterial Agents; Antiviral Agents; Brain; Brain Ischemia; Ceftriaxone; COVID-19; COVID-19 Drug Treatment; Fever; Frontal Lobe; Humans; Infant, Newborn; Infant, Newborn, Diseases; Lethargy; Magnetic Resonance Imaging; Male; Nasopharynx; SARS-CoV-2; Seizures

Ceftriaxone kinetics were characterized after a single, 2-minute, intravenous infusion of 50 mg/kg to 20 sick infants 1 to 8 days old who weighed 1.78 to 4.36 kg. Plasma binding parameters could be determined by equilibrium dialysis in 16 of the infants, in whom kinetic parameters for free ceftriaxone in plasma were also determined. Compared with corresponding values in adults, the elimination t1/2 was longer in infants (19 and 8.4 hours) because of reduced total systemic clearance (4.48 and 8.51 ml/min/m2). The apparent steady-state volume of distribution was of the same order in infants and adults (5,130 and 5,350 ml/m2). Both renal and nonrenal clearance of free ceftriaxone were reduced in infants, but these decreases were partially offset by an increased free fraction; plasma binding affinity and capacity constants for infants were about half the adult values. The mean fraction of dose excreted unchanged in urine was estimated at 70% in the neonates and 46% in adults. There were no clinically significant correlations between the kinetic parameters and either age since birth or age since conception. The fraction of free ceftriaxone in plasma inversely correlated with age since conception and was lower in female infants, which decreased the systemic clearance and volume of distribution of total drug in the female infants compared with the male infants. Values for the volume of distribution and clearance parameters were not related to body size (weight or body surface area). From our results, a ceftriaxone dosage of 50 to 100 mg/day is recommended during the first week of life for newborn infants who weigh between 1.8 and 4.4 kg. Impaired renal function may require a reduction in dosage.

Topics: Adult; Blood Proteins; Cefotaxime; Ceftriaxone; Female; Glomerular Filtration Rate; Half-Life; Humans; Infant, Newborn; Infant, Newborn, Diseases; Infusions, Parenteral; Kinetics; Male; Protein Binding

A group of 104 neonates with clinical signs of infection sufficient to justify treatment with penicillin plus gentamicin received instead monotherapy with ceftriaxone (50 mg/kg once daily). Bacteriological cultures from 20 babies before treatment yielded significant isolates (9 had bacteraemia). Following treatment, infecting bacteria were eradicated from 15/20 babies. Ten of the 104 babies died; all were examined post mortem. Only one death was attributed to bacterial infection. The remaining babies responded well to treatment. No adverse alteration in biochemical or haematological values was associated with ceftriaxone therapy. The incidence of diarrhoea, blood in the stools, necrotising enterocolitis or anti-coagulation problems was the same as in the babies not receiving ceftriaxone. Pharmacokinetic values were determined on 40 babies. Elimination half life (T1/2 beta) and minimum serum concentration (Cmin.) decreased and clearance increased with increasing postnatal age. Postnatal age was the single most significant factor affecting pharmacokinetics. Ceftriaxone is a safe and effective alternative to conventional therapy for infected neonates. Prolonged therapy is associated with superficial colonisation with inherently resistant bacteria.

Topics: Bacterial Infections; Cefotaxime; Ceftriaxone; Female; Humans; Infant, Newborn; Infant, Newborn, Diseases; Kinetics; Male; Respiratory Tract Infections; Sepsis

Ceftriaxone pharmacokinetics were determined in 40 newborn infants who were 1 to 45 days of age. Mean peak plasma concentrations of 136 to 173 micrograms/ml were observed at the completion of a 15-min intravenous infusion of 50 mg of ceftriaxone per kg. Mean half-life values were 5.2 to 8.4 h, and mean plasma clearances were 0.7 to 1.8 ml/min. Rectal swab cultures from 14 of 16 infants had either reduced numbers of aerobic and anaerobic bacteria or no growth during therapy. A once-daily dosage schedule is suggested for ceftriaxone therapy in newborn infants.

Topics: Anti-Bacterial Agents; Bacterial Infections; Cefotaxime; Ceftriaxone; Humans; Infant; Infant, Newborn; Infant, Newborn, Diseases