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Search / Trial NCT05248477

Improve the Survival Without Morbidity of Extremely Preterm Infants (PREMEX)

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Feb 9, 2022

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Extremely Preterm Infants Periviable Birth Perinatal Management Exprim Protocol

ClinConnect Summary

The PREMEX trial is studying a new way of caring for extremely premature infants, those born between 22 and 26 weeks of pregnancy. The goal is to improve their chances of survival without serious health issues. This approach involves a team of healthcare professionals working together to provide early and organized care for both the mothers and their babies who are at risk of early delivery. The trial will involve collecting information from parents about their experiences during and after their child's care, as well as tracking the child's development as they grow.

To participate in this study, mothers need to be hospitalized due to the risk of premature delivery, and they should be able to understand French or have someone who can help with communication. Babies eligible for the study include those born alive or stillborn during the specified weeks of pregnancy. Throughout the trial, parents can expect to fill out questionnaires about their experiences and their child's health, with follow-ups extending until the child is two years old to assess their development. This research aims to create better care practices for the tiniest and most vulnerable infants.

Gender

ALL

Eligibility 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

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

Patients applied

0 patients applied

Trial Officials

Pierre-Henri JARREAU, MD, PhD

Study Director

Assistance Publique - Hôpitaux de Paris

Pierre-Yves ANCEL, MD, PhD

Study Chair

Assistance Publique - Hôpitaux de Paris

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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