Clinical Trial

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

Study acronym: TOCOKIDS
Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-22.
Status change: Not Yet Recruiting → Recruiting 2026-02-11
Trial Details
NCT Number NCT07146451
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions Children Born to Mothers Enrolled in the TOCOPROM Trial
Enrollment 480 participants
Start Date 2025-10-28
Primary Completion 2033-09 (estimated)
Study Completion 2034-09 (estimated)
Updated on ClinicalTrials.gov 2026-02-13