A New Approach to Prevent Neonatal Respiratory Distress Syndrome: A randomized clinical trial of 25(OH) D Injections before Preterm Delivery

Abstract

BackgroundVitamin D deficiencies have been suggested as one of the risk factors for neonatal respiratory distress syndrome (RDS). The present study aimed to evaluate the effect of 25-hydroxyvitamin D [25(OH)D] administration in pregnant women at risk of preterm delivery on the incidence of RDS in their preterm neonates.MethodsA single-blinded randomized controlled clinical trial was conducted on pregnant mothers with a gestational age of less than 34 weeks at risk of preterm delivery. Subjects were randomly assigned into two groups by the corresponding author, including intervention (intramuscular injection of 50,000 units of 25(OH) D three days before delivery) and control (with no injection of 25(OH) D). Serum concentrations of 25(OH) D were measured after offspring, including RDS, were collected and recorded in a checklist. Short-term outcomes and the need for respiratory support were assessed by the principal investigator who was unaware of the type of intervention. Data were analyzed by independent t-test, paired sample t-test, and chi-square test.ResultsDespite the homogeneity of neonates in the two groups in terms of gestational age, birth weight and the delivery method, 45% of neonates in the control group and 20% in the intervention group developed respiratory distress syndrome (P < 0.05). The mean 25(OH) D level in neonates was 17.7 ± 10.5 and 23.7 ± 13.5 ng/mL in the intervention and control groups, respectively.ConclusionsAccording to this study, a single dose of 50,000 units of intramuscular 25(OH) D in pregnant women at risk of preterm delivery can reduce the incidence of RDS in the newborn.Trial RegistrationIranian Registry of Clinical Trials, IRCT20190814044529N1. Registered 21st Jan. 2020, https://fa.irct.ir/user/trial/41515/view