Objective: Our randomized, double-blind, placebo-controlled trial of transdermal nitroglycerin (GTN) for preterm labour demonstrated a significant reduction in neonatal morbidity and mortality. The objective of this study was to evaluate developmental performance in the children born to women who participated in the GTN trial after one year and two years of follow-up.
Methods: The Ages and Stages Questionnaires (ASQ) were used for the assessments, and five domains of child development (communication, gross motor skills, fine motor skills, problem-solving, and personal social skills) were evaluated. Supplementary analyses were performed after stratifying study subjects by gestational age at birth (< 28, 28 to 32, 33 to 36, ≥ 37 weeks) or by defining study subjects as normal or abnormal using standard cut-offs.
Results: A total of 153 infants born to women who participated in the GTN trial were included in the initial follow-up. Among them, 111 (72.5%) children (55 in the GTN arm and 56 in the placebo arm) at 12 months of age and 83 (54.2%) children (42 in the GTN arm and 41 in the placebo arm) at 24 months of age completed the full ASQ. There were no differences in ASQ total score and five subscores between the GTN arm and the placebo arm at the one-year and two-year follow-up evaluations, in overall study subjects, or after stratifying study subjects by gestational age. A trend towards reduced abnormalities in the GTN arm at the two-year follow-up was observed, although there was no statistical significance.
Conclusion: Maternal GTN use for preterm labour had no impact on children's long-term development, but larger studies are needed to confirm the preliminary findings of this study.