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

Not yet recruitingOBSERVATIONAL
Enrollment

480

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

September 30, 2033

Study Completion Date

September 30, 2034

Conditions
Children Born to Mothers Enrolled in the TOCOPROM Trial
Interventions
OTHER

Self-administered parental questionnaire

A self-administered parental questionnaire, completed online or on paper, to assess different dimension of neurodevelopment

OTHER

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)."

Trial Locations (1)

75012

Trousseau University Hospital, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT07146451 - 6-year Outcomes in Children After Nifedipine vs Placebo for Preterm Prelabor Rupture of Membranes at 22-33 Weeks | Biotech Hunter | Biotech Hunter