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

Recruiting now · Has a placebo group

Conditions studied: Children Born to Mothers Enrolled in the TOCOPROM Trial

In brief

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.

Key facts

Study ID

NCT07146451

Run by

Assistance Publique - Hôpitaux de Paris

People needed

480

Starts

2025-10-28

Expected to finish

2034-09-01

Last updated by the study team

2026-02-13

Who can join

Age: 6 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Major malformations and/or chromosomal aberrations evidenced after birth
• Impossibility to contact the family
• Opposition to participate in the follow-up

Where it is running

• Trousseau University Hospital — Paris, France, France (enrolling)

Full record on ClinicalTrials.gov

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