Improving care for extremely preterm infants
Official title: Improve the Survival Without Morbidity of Extremely Preterm Infants: a Stepped-wedge Cluster-randomized Trial
Run by Assistance Publique - Hôpitaux de Paris · NCT05248477 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is trying a new care plan for mothers at risk of having extremely preterm babies to see if it can improve the health and survival of their infants.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 2100 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05248477 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include mothers hospitalized between 22 and 26 weeks of gestation due to the risk of preterm delivery, along with their newborns.
✕Probably not a fit
Patients who deliver before 22 weeks or after 26 weeks of gestation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study implements the EXPRIM protocol, which focuses on early, standardized, and multidisciplinary management of women at risk of extremely preterm birth and their infants. It targets mothers hospitalized between 22 and 26 weeks of gestation and aims to reduce variability in care practices across different regions. The study will collect feedback from parents regarding their experiences with the information provided and the care received for their child at specific intervals post-delivery. The goal is to enhance survival rates and reduce morbidity for extremely preterm infants.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and reduce complications for extremely preterm infants.
How similar studies have gone: Other studies have shown that standardized care protocols can improve outcomes for preterm infants, suggesting this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hôpital Cochin
Paris, France Recruiting
Study contacts
- Study coordinator: François GOFFINET, MD, PhD
- Email: francois.goffinet@aphp.fr
- Phone: +33 1 58 41 37 98
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High-energy DHA/ARA-enriched human milk in the first 2 weeks to lower lung problems in extremely preterm babies
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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.