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Search / Trial NCT06811064

Involving Family Stakeholders in the NICU: a New Perspective to Improve Quality of Life. PAREN

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · Jan 31, 2025

Trial Information

Current as of June 27, 2025

Not yet recruiting

Keywords

Resource Parents Quality Of Life Premature Newborn Neonatal Intensive Care Unit

ClinConnect Summary

This clinical trial, titled "Involving Family Stakeholders in the NICU," aims to improve the quality of life for families with premature newborns who are in the neonatal intensive care unit (NICU). The study will explore how involving experienced parents—those who have previously navigated the NICU—can help current parents feel more confident and connected to their babies during their hospital stay. The trial will include parents of premature newborns who are under 37 weeks gestation and have been in the NICU for at least one week. Parents must be 18 years or older and agree to participate in the study.

Participants can expect to watch testimonial videos made by resource parents, which will provide support and guidance during key moments of their child's care. Before and after their baby’s transition between different care units, parents will complete surveys to measure how they feel about their ability to care for their child and their overall family quality of life. The goal is to see if this support leads to better early interactions with their babies and improves family well-being after one year. It’s important to note that newborns at term (37 weeks or older) and those whose parents do not wish to participate are not eligible for the study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Premature newborn (\<37 weeks of amenorrhoea)
  • Newborn whose parents are aged 18 or over
  • Newborns who have spent at least one week in a neonatal intensive care unit,
  • Newborn baby hospitalised in one of the neonatology/intensive care unit
  • Newborn for whom both or one of the two parents have expressed their non-opposition to taking part in the study or Newborn for whom the only legal representative (single-parent family) has expressed his/her non-opposition to taking part in the study.
  • Exclusion Criteria:
  • Newborns at term (≥ 37 SA);
  • Newborns in which both or one of the parents refuse to participate or newborns in which the only legal representative (single-parent family) has expressed opposition to participating in the study.
  • Newborn whose two parents or one of them withdraws their non-opposition
  • Newborn transferred to another neonatal intensive care unit during hospital stay;
  • Newborn child who dies during hospitalisation or after discharge up to the one-year visit.
  • Newborn lost to follow-up at 1 year.

About Assistance Publique Hopitaux De Marseille

Assistance Publique - Hôpitaux de Marseille (AP-HM) is a leading public healthcare institution in France, dedicated to providing high-quality medical care and advancing research in various clinical fields. As a prominent sponsor of clinical trials, AP-HM is committed to fostering innovation and improving patient outcomes through rigorous scientific investigation. With a multidisciplinary approach, the institution collaborates with a network of healthcare professionals, researchers, and academic partners to facilitate cutting-edge studies that address critical health challenges. AP-HM's dedication to ethical standards and patient safety underscores its role as a trusted leader in clinical research and healthcare delivery.

Locations

Marseille, , France

Patients applied

0 patients applied

Trial Officials

Mathilde LEFEVRE

Study Director

assistance Publique Hôpitaux de Marseille

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported