Goat lung surfactant for treatment of respiratory distress syndrome among preterm neonates: a multi-site randomized non-inferiority trial.

OBJECTIVE: To investigate the safety and efficacy of goat lung surfactant extract (GLSE) compared with bovine surfactant extract (beractant; Survanta®, AbbVie, USA) for the treatment of neonatal respiratory distress syndrome (RDS). STUDY DESIGN: We conducted a double-blind, non-inferiority, randomized trial in seven Indian centers between June 22, 2016 and January 11, 2018. Preterm neonates of 26 to 32 weeks gestation with clinical diagnosis of RDS were randomized to receive either GLSE or beractant. Repeat dose, if required, was open-label beractant in both the groups. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age (PMA). Interim analyses were done by an independent data and safety monitoring board (DSMB). RESULT: After the first interim analyses on 5% enrolment, the "need for repeat dose(s) of surfactant" was added as an additional primary outcome and enrolment restricted to intramural births at five of the seven participating centers. Following second interim analysis after 98 (10% of 900 planned) neonates were enroled, DSMB recommended closure of study in view of inferior efficacy of GLSE in comparison to beractant. There was no significant difference in the primary outcome of death or BPD between GLSE group (n = 52) and beractant group (n = 46) (50.0 vs. 39.1%; OR 1.5; 95% CI 0.7-3.5; p = 0.28). The need for repeat dose of surfactant was significantly higher in GLSE group (65.4 vs. 17.4%; OR 9.0; 95% CI 3.5-23.3; p < 0.001). CONCLUSIONS: Goat lung surfactant was less efficacious than beractant (Survanta®) for treatment of RDS in preterm infants. Reasons to ascertain inferior efficacy of goat lung surfactant requires investigation and possible mitigating strategies in order to develop a low-cost and effective surfactant.

Evaluation of body parameters for estimation of endotracheal tube length in Indian neonates.

UNLABELLED: The objectives were to estimate the incidence of inadequate placement of the endotracheal tube (ET) using Tochen's formula (6 + birth weight) and to correlate optimum ET length with anthropometric measurements in neonates. A cross-sectional analytical study was conducted in 50 neonates. Neonates requiring intubation for ventilation, with a confirmatory chest radiograph, were intubated using Tochen's formula, after which tube placement was verified by auscultation. The incidence of inadequate placement and optimum length of ET insertion were estimated from chest radiographs. Anthropometric parameters were measured and correlated with the optimum length and regression equations generated. The incidence of inadequate placement of the ET was 40 % (20 of 50). The incidence of inadequate placement was higher (5 of 6, 83 %) in extremely low birth weight (ELBW) infants, and in extreme preterm infants (5 of 5, 100 %). It was found that all the anthropometric parameters correlated well (r between 0.71 and 0.84) with the optimum ET length. CONCLUSION: The incidence of inadequate placement was high, especially in the ELBWs' and extreme preterm infants. Birth weight, sternal length, and shoulder umbilical length correlated significantly with optimum ET length and may guide optimal ET placement.

Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers given with routine vaccines in India.

BACKGROUND: The childhood burden of disease attributable to Streptococcus pneumoniae is particularly high in India. The immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) were compared with 7-valent pneumococcal conjugate vaccine (PCV7) in a randomized, active-controlled, double-blind trial conducted at 12 sites in India. METHODS: Healthy infants received PCV13 or PCV7 at 6, 10, and 14 weeks of age (infant series) and at 12 months of age (toddler dose), along with routine pediatric vaccinations. Immunoglobulin G responses against the 13 pneumococcal serotypes were evaluated 1 month after the infant series and after the toddler dose. Pertussis and poliomyelitis immune responses were assessed 1 month after the infant series. Safety and tolerability also were assessed. RESULTS: The immunogenicity results for the 7 common serotypes and the concomitant vaccines (whole-cell pertussis and oral poliovirus) were similar for subjects receiving PCV13 and subjects receiving PCV7. Immune responses to the 6 additional serotypes were higher in the PCV13 group compared with the PCV7 group. PCV13 and PCV7 had similar safety and tolerability profiles. CONCLUSIONS: PCV13 has immunogenicity similar to PCV7 in response to the 7 common serotypes, and has generally higher immunogenicity in response to the 6 additional serotypes. PCV13 may provide added protection against pneumococcal disease caused by the additional 6 serotypes and does not interfere with immune responses to whole-cell pertussis and oral poliovirus vaccines. PCV13 has an acceptable safety profile in both infants and toddlers, comparable with that of PCV7.

Hypercalcemia in extremely low birth weight neonates.

Hypercalcemia is rare in neonates but may be associated with hypophosphatemia in Extremely low birth weight (ELBW) neonates who are on parenteral nutrition without adequate phosphate supplementation.

Dehydration and hypernatremia in breast-fed term healthy neonates.

OBJECTIVE: The aim of the study was to determine the incidence of significant weight loss, dehydration, hypernatremia and hyperbilirubinemia in exclusively breast-fed term healthy neonates and compare the incidence of these problems in the warm and cool months. METHODS: During the study period 496 neonates were recruited. RESULTS: 157 neonates (31.6%) had significant weight loss (> 10 % cumulative weight loss or per day weight loss > 5%). Clinical dehydration was present in 2.2% of neonates. Of these 157 neonates, 31.8% had hypernatremia and 28 % had hyperbilirubinemia. CONCLUSION: The incidence of the above mentioned problems were higher in the warm months but the difference was not statistically significant.