Controlled trial of prenatal Thyrotropin-Releasing Hormone (TRH) and Betamethasone (B) for prevention of Respiratory Distress Syndrome (RDS).• 965

Abstract

The use of TRH in conjunction with corticosteroids to prevent RDS in preterm pregnancies remains controversial. We conducted a multicenter, double-blind, randomized, controlled trial of prenatal administration of TRH(400 mg iv in 50 ml NS, q 8 h × 4) or placebo (PLC, 50 ml NS iv at same times) in women with singleton pregnancies ≤ 32 weeks' gestational age (GA) with threatened preterm delivery. All women in the trial received B (12 mg im q 24 h × 2). Live-born neonates < 1.0 kg received Exosurf soon after birth, whereas those ≥ 1.0 kg only received Exosurf as rescue therapy. The primary outcome of the study was RDS. A total of 370 women entered the trial(TRH n=190, PLC n=180) and 85% of them received all doses of TRH or PLC. GA at entry were 29.0 ± 2.2 vs 28.2 ± 2.3 d (mean ± SD), respectively. No benefits of maternal use of TRH were seen in either all neonates in the study or in the subgroup delivered between 1-10 days from entry. Air leaks were more common in the TRH group (7.0% vs 1.9%, respectively, RR= 1.38 i1.20-2.09, 95% C.I.ý).Other maternal or neonatal complications were similar in both groups. These data do not support the use of TRH in conjunction with B to prevent RDS when there is widespread surfactant availability. Funded by FONDECYT grant 193-0854.Table