Improving care for extremely preterm infants
Improve the Survival Without Morbidity of Extremely Preterm Infants: a Stepped-wedge Cluster-randomized Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2100 (estimated) |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05248477 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who deliver before 22 weeks or after 26 weeks of gestation will not benefit from this study.
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 performed: Other studies have shown that standardized care protocols can improve outcomes for preterm infants, suggesting this approach may be effective.
Eligibility criteria
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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.