6-year Outcomes in Children After Nifedipine vs Placebo for Preterm Prelabor Rupture of Membranes at 22-33 Weeks
6-year Follow-up of Children Born to Mothers Exposed to Nifedipine vs Placebo After Preterm Prelabor Rupture of Membranes at 22 to 33 Weeks of Gestation
Assistance Publique - Hôpitaux de Paris
480 participants
Oct 28, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- Major malformations and/or chromosomal aberrations evidenced after birth
- Impossibility to contact the family
- Opposition to participate in the follow-up
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Interventions
A self-administered parental questionnaire, completed online or on paper, to assess different dimension of neurodevelopment
NEMI-3: an intelligence test administered by a psychologist measuring a fluid and crystallised intelligence. The test consists of 117 spoken and visual questions, for a total administration time of 45 min. Results are expressed in the form of standard indices (mean 100, standard deviation 15) that facilitate comparisons with the results obtained on other intelligence scales. Results will be classified as normal, mild delay (between 1 and \<2 standard deviation \[SD\] below the mean) or severe delay (≥2 SD).
Locations(1)
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NCT07146451