Objective: To evaluate neurodevelopmental outcome until 2 years of age in children who participated in a multicenter antenatal thyrotropin-releasing hormone (TRH) trial to improve respiratory outcome and to lower mortality.
Methods: Neurodevelopmental outcome was studied in infants whose mothers were admitted to the Academic Medical Center and enrolled in the European Antenatal TRH trial. Mothers were treated for imminent preterm delivery (before 30 weeks) with corticosteroids plus either placebo (placebo-group) or TRH (TRH-group). TRH treatment consisted of 400 micro g every 8 hours up to 4 doses. Assessments included neurologic development at 12 months and psychomotor development at 12 and 24 months using the Bayley developmental scales.
Results: Sixty-two infants were included, 10 of whom died. Of the surviving infants, 24 received TRH and 28 received placebo. Ten infants were lost to follow-up. Each group consisted of 21 infants. Both groups were comparable regarding gestational age, birth weight, and time interval between trial medication and birth. However, in the TRH group, more respiratory problems, ventilator days, and chronic lung disease were found. Neurologic and motor outcome did not differ between the groups, but lower mental developmental index scores were found in the TRH group at both ages.
Conclusions: Antenatal TRH treatment is associated with a delay in mental development. This study demonstrates the importance of long-term follow-up of perinatal intervention trials with possible consequences for neurodevelopmental outcome of the infant.