JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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Intra-amniotic instillation of surfactants for the prevention of neonatal respiratory distress syndrome following preterm delivery.

OBJECTIVE: To assess the efficacy of intra-amniotic administration of surfactants in reducing the incidence and severity of respiratory distress syndrome (RDS), and the need for postnatal endotracheal surfactant during preterm delivery.

METHODS: A prospective pilot study enrolled pregnant women at 28-34 weeks of pregnancy between July 1, 2013 and December 31, 2014 who were randomly assigned in a 1:1 ratio to a control group or to receive intra-amniotic surfactant (3mL) administered under ultrasonography guidance within 2-8 hours of expected delivery. The primary outcomes, the incidence and severity of RDS, and the need for postnatal surfactants, were analyzed on an intention-to-treat basis.

RESULTS: The study enrolled 20 patients to each group. The incidence of RDS did not differ between the two groups (P=0.110). Severe RDS was more common in the control group (P=0.018) and postnatal surfactants were required more frequently in the control group (P=0.02).

CONCLUSION: Intra-amniotic administration of surfactants reduced RDS severity and the need for postpartum endotracheal surfactants. Clinical Trials Registry India: CTRI/2015/12/006399.

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