There are conflicting data in the literature concerning the reduction of RDS and CLD by antenatal TRH. We performed a trial involving 13 North American Centers between October 1992 and December, 1996. 985 women in preterm labor at≤30 wks were entered into this randomized, blinded controlled study of antenatal TRH and 784 (83%) received a full treatment course (400 μgTRH or placebo Q 8 h × 4). All women received antenatal corticosteroids and infants received postnatal surfactant when appropriate. 21.4% women experienced the known side effects; nausea (20%) and/or vomiting (6.6%). The infusion was stopped in 29 (3.0%) mothers for maternal or fetal reasons. There were no significant adverse events in mothers or infants felt to be related to TRH. Blinded outcome data are available for 914 women and their 1010 infants who were entered into the study prior to September 1, 1996 (92.8% of total entered). 681 of these infants (67.4%) delivered in the at risk group for CLD(≤32 weeks gestation). The mean BW and GA of the total and at risk groups were 1578.9 ± 836.5 gm, 30.5 ± 4.4 wk, and 1106.0 ± 359.5 gm, 27.9 ± 2.0 wk, respectively. The incidence of RDS, CLD at 28 days and CLD at 36 wks postconceptional age in the total group were 48.8%, 21.1%, and 15.8% and in the at risk group 65.9%, 29.5%, and 20.9%, respectively. Outcome data will be available on all infants in the trial by April 1997 and the study will be unblinded at that time.

Funded by NIH1-RO1-HD29201, NIH MO1-RR00040, NIH MO1-RR000425, NIH MO1-RR01271, and Perinatal Associates, Inc.).