Six-year outcomes for children exposed to nifedipine or placebo after early preterm membrane rupture
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
Run by Assistance Publique - Hôpitaux de Paris · NCT07146451 · Data updated 2026-11-12
This follow-up will test whether a short course of nifedipine given before birth affects neurodevelopment at age 6 in children born after preterm rupture of membranes at 22–33 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years to 78 Months |
| Sex | All |
| Enrollment | 480 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, France) |
| Status | Recruiting |
| Started | October 28, 2025 |
| Main results expected | September 2033 |
| Study ends | September 2034 |
| Registry record updated | February 13, 2026 |
| Trial ID | NCT07146451 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children born to mothers randomized in the TOCOPROM trial who are alive at 6 years, whose caregivers previously consented to follow‑up and agree to be contacted, and who have internet access for online testing are eligible.
✕Probably not a fit
Children with major malformations or chromosomal abnormalities, families who cannot be contacted or who decline participation, and those without reliable internet/video access are excluded and unlikely to benefit from this follow‑up.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational 6-year follow-up of children whose mothers took part in the randomized TOCOPROM trial comparing 48‑hour nifedipine versus placebo for preterm prelabor rupture of membranes at 22–33 weeks. Children alive at age 6 whose caregivers consented will complete a self‑administered parental questionnaire and a short online psychological assessment by video conference. Investigators will compare school‑age neurodevelopmental and psychological outcomes between those prenatally exposed to nifedipine and those exposed to placebo. The protocol excludes major congenital or chromosomal anomalies and requires internet/video access for the assessment.
Why it matters
Potential benefit: If successful, the results could clarify whether short‑term maternal nifedipine before delivery changes long‑term neurodevelopment and help guide treatment decisions in early PPROM.
How similar studies have gone: Prior trials of tocolysis in PPROM have mainly reported short‑term perinatal outcomes, and robust long‑term neurodevelopmental data after nifedipine exposure are limited, making this follow‑up relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Major malformations and/or chromosomal aberrations evidenced after birth * Impossibility to contact the family * Opposition to participate in the follow-up
Where it's running
-
Trousseau University Hospital
Paris, France, France Recruiting
Study contacts
- Principal investigator: Gilles KAYEM, MD,PhD — Université Paris Cité and Université Sorbonne Paris Nord, Paris, France. DHU Risks in Pregnancy, Paris Descartes University, Trousseau University Hospital
- Study coordinator: Gilles KAYEM, MD,PhD
- Email: gilles.kayem@aphp.fr
- Phone: 01 44 73 51 18
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.