Nasal continuous positive airway pressure with mask as interface is as effective as prongs but causes less nasal trauma and pulmonary interstitial emphysema.
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.
Poland-Mobius syndrome is a rare congenital disorder that includes features of Poland and Mobius syndromes. It is characterized by unilateral or bilateral congenital facial weakness, impairment of abduction of eyes, associated limb anomalies, and aplasia or hypoplasia of the pectoralis muscle. We describe a case of Poland-Mobius syndrome in a neonate associated with unilateral vocal cord immobility.
Background: Critical congenital heart disease (CCHD) if undiagnosed in the first few days of life is associated with high morbidity or and mortality. Pulse oximeter screening for CCHDs in newborn babies can aid in early recognition with the prospect of improved outcome. Routine pulse oximetry screening of asymptomatic infants for CCHD is prevalent in developed countries but not in India. Aims: To estimate the diagnostic accuracy of screening for CCHD with a new generation pulse oximeter in a setting of a public hospital in India. Materials and Methods: A prospective observational study including all term neonates (>37 weeks) admitted to the postnatal ward. Results: 1594 term newborns were screened by pulse oximetry. Of these, 1589 (99.69%) neonates passed the screening and 5 failed the test. For CCHD, sensitivity was found to be 100% with a specificity of 99.94% and positive and negative predictive value was 80% and 100%, respectively. Peripheral perfusion index (PPI) was 2.04 in infants who passed the test in comparison to 0.65 in those who failed the test. Conclusion: Pulse oximetry has a high sensitivity, specificity, and negative predictive value for detection of CCHD in newborn infants. PPI is a good predictor of systemic hypoperfusion in CCHD.
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