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

Recruitingn/aAges 6 Years - 78 MonthsAllAssistance Publique - Hôpitaux de Paris
NCT07146451 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Self-administered parental questionnaire
  • A short psychological assessment performed online
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Where

1 site
Trousseau University Hospital
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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