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

NCT07146451 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 480

Last updated 2026-02-13

No results posted yet for this study

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.

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).

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Gilles KAYEM, MD,PhD · Université Paris Cité and Université Sorbonne Paris Nord, Paris, France. DHU Risks in Pregnancy, Paris Descartes University, Trousseau University Hospital

  • Elsa LORTHE, RM,PhD · Université Paris Cité and Université Sorbonne Paris Nord, Paris, France.

Eligibility

Min Age
6 Years
Max Age
78 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2033-09-30
Completion
2034-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07146451 on ClinicalTrials.gov