Effect of Antenatal Corticosteroids in Late Preterm Delivery on Neonatal Respiratory Morbidity: A Randomized Controlled Trial.

Abstract

Background: The use of antenatal corticosteroids beyond 34 weeks of gestation to prevent certain neonatal complications remains a debate. This study sought to determine the effect of the use of antenatal corticosteroids in late preterm delivery on neonatal morbidity.

Methodology: It was a randomized double-blind placebo and active-controlled multi-arm trial. There were two study groups and one control group. It was conducted at the Department of Obstetrics and Gynaecology and the Department of Paediatrics of Ahmadu Bello University Teaching Hospital Zaria, Nigeria. Pregnant women at 34 weeks to 36 weeks 6 days of gestation scheduled for elective delivery or who had emergency delivery were recruited for the study. The first study group had 2 doses of 12mg intramuscular dexamethasone and the second study group had 2 doses of 12mg betamethasone. The control group had 2 doses of a placebo. The primary outcome was the incidence of respiratory distress syndrome evidenced by tachypnoea with grunting, recession, or nasal flaring with diffuse reticulogranular infiltrate on X-ray or respiratory distress requiring the need for respiratory support by 72 hours of age. Secondary outcome measures included the need for neonatal resuscitation at birth, admission into the Special Care Baby Unit/Neonatal Intensive Care Unit, transient tachypnoea of the newborn, and apnoea.

Results: A total of 138 mothers and 146 preterm neonates were included. A pairwise analysis was done to test for differences between the groups. There was no difference in the incidence of respiratory distress syndrome between the groups. However, the need for neonatal resuscitation was significantly higher (RR: 7.0; CI: 2.49-19.4; p = <0.001) in the placebo group when compared to the betamethasone group and also significantly higher (RR:4.0; CI: 1.86-26.03; p= 0.01) in the placebo group when compared to the dexamethasone group.

Conclusion: Antenatal corticosteroids may decrease the need for neonatal resuscitation at birth in late preterm neonates.

Funding: The research was funded by the Tertiary Education Trust Fund (TETFUND) of Nigeria. Trial registration: ClinicalTrial.gov, NCT03446937.