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6-year Outcomes in Children After Nifedipine vs Placebo for Preterm Prelabor Rupture of Membranes at 22-33 Weeks
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Official title: 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
Key Details
Gender
All
Age Range
6 Years - 78 Months
Study Type
OBSERVATIONAL
Enrollment
480
Start Date
2025-10-28
Completion Date
2034-09
Last Updated
2026-02-13
Healthy Volunteers
No
Interventions
Self-administered parental questionnaire
A self-administered parental questionnaire, completed online or on paper, to assess different dimension of neurodevelopment
A short psychological assessment performed online
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)
Trousseau University Hospital
Paris, France, France