Follow-Up at Age 6 of Children Born to Mothers Treated With Nifedipine or Placebo After Preterm Prelabor Rupture of Membranes Between 22 and 33 Weeks

What this Trial Is About

Researchers are evaluating the neurodevelopmental outcomes at age 6 of children born to women who experienced preterm prelabor rupture of membranes PPROM between 22 and 33 weeks of pregnancy. This study compares antenatal exposure to nifedipine versus placebo to understand potential effects on child development after early membrane rupture, a condition linked to preterm birth and associated risks for both mother and child. The trial includes two groups one exposed to oral nifedipine with a loading dose followed by maintenance doses over 48 hours, and the other exposed to a matching oral placebo. The original TOCOPROM trial assessed short-term tocolysis effects, and this follow-up, called TOCOKIDS, aims to assess longer-term developmental effects at school age. Participants will complete a self-administered parental questionnaire online or on paper, and children will undergo a brief remote psychological assessment by video conference. Researchers will collect health data from medical records and assess multiple developmental domains including cerebral palsy, coordination, language, behavior, and executive functions. The study monitors neurodevelopmental and health outcomes up to 6 months after inclusion, with a total follow-up period reaching 6 years of age.

6-year Outcomes in Children After Nifedipine vs Placebo for Preterm Prelabor Rupture of Membranes at 22-33 Weeks