RecruitingNot Applicable

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

France480 participantsStarted 2025-10-28

Plain-language summary

The purpose of this study is to evaluate the neurodevelopment at age 6 of children born to women with preterm prelabor rupture of membranes at 22 to 33 weeks of gestation, after antenatal exposure to nifedipine vs placebo.

Who can participate

Age range6 Years – 78 Months

SexALL

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Inclusion Criteria: * All children born to mothers enrolled in the TOCOPROM trial who consented to participate in the 2-year follow-up and who agreed to be contacted for the 6-year follow-up * Alive at 6 years * Internet access, including access to a good-quality video-conference system (only for the psychological evaluation) * Non opposition of the holders of the exercise of parental authority Exclusion Criteria: * Major malformations and/or chromosomal aberrations evidenced after birth * Impossibility to contact the family * Opposition to participate in the follow-up