Status:
ACTIVE_NOT_RECRUITING
Improve the Survival Without Morbidity of Extremely Preterm Infants (PREMEX)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Newborn
Extreme Prematurity
Eligibility:
All Genders
Phase:
NA
Brief Summary
The intervention proposed is a new organization of care, based on the EXPRIM (EXtrem PRematurity Innovative Management) protocol, involving early, standardized, and multidisciplinary management of wom...
Detailed Description
Extremely preterm infants, those born between 22 and 26 weeks of gestation, are at very high risk of neonatal death, severe morbidity, and disabilities. These children's survival basically depends on ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Mothers:
- women hospitalized between 22 and 26 weeks for risk of preterm delivery with a fetus alive or dead at admission and with a delivery between 22 and 26 completed weeks
- understanding of the French language by the woman or in the immediate entourage in charge of the child.
- Children: all newborns (live- and stillborn) delivered between 22 and 26 weeks.
- Exclusion Criteria
- women who object to the use of their routine perinatal data,
- women giving birth before 22 weeks and after 26 completed weeks.
- woman to legal protection (subject protected by law under guardianship or curatorship)
- Women undergoing a termination of pregnancy (TOP) for severe congenital anomaly or psycho-social contexte
Exclusion
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
2377 Patients enrolled
Trial Details
Trial ID
NCT05248477
Start Date
June 1 2022
End Date
December 1 2026
Last Update
November 20 2025
Active Locations (1)
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1
Hôpital Cochin
Paris, France, 75014