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

NCT06811064 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1008

Last updated 2025-02-06

No results posted yet for this study

Summary

Introduction Thanks to medical advances in neonatal care, the majority of children admitted to the neonatal intensive care unit (NICU) survive and enjoy a good quality of life. At the same time, medical practices and philosophy of neonatal care have changed and families are playing an increasingly important role in their child's care. However, stress and anxiety generated by hospitalization and complex technologies of neonatal intensive care units may be an obstacle to integrate parents and help them take ownership of their role. A number of measures have been established to improve the experience of parents in neonatology, such as multidisciplinary care, involving psychologists, social workers, spiritual care workers, psychomotor therapists and physiotherapists.

Among these interventions, the introduction of resource parents (RPs), parents who have previously been involved in neonatology, is a new initiative that is growing rapidly in North America. These RPs bring a unique perspective based on their experiential knowledge. This partnership model is still underdeveloped in France, and its impact on parents' quality of life and early interactions with their children has been little studied or described.

Method Our aim is therefore to develop a PR intervention in neonatology units and measure its impact in the short and medium term, with a prospective multicenter step wedge study.

The chosen intervention will be co-constructed with PRs. It will take the form of testimonial videos focusing on one of the key moments in the care of newborn babies: the transition from different neonatology units. These videos will then be viewed by parents of hospitalized newborn in the units at the time of their transition. A survey assessing the parents' Self Perceived Efficacity in taking care of their child will be administered when the child transitions to the neonatal unit and then again when the child is discharged from the hospital. At the one-year old visit, the families' quality of life will be assessed using another standardized survey: the Pediatric Quality of Life Inventory (PedsQLTM2.0) - Family Impact Module.

Perspective Our hypothesis is that a PR intervention at a key point in the newborn's care pathway can help parenthood and have a positive impact on early interactions and quality of life at 1 year.

Conditions

  • Premature Birth

Interventions

OTHER

Testimony video

A testimonial video on the experiences of parents of premature babies during the transfer of their newborn from the intensive care unit to the neonatal unit. This video will be performed with the collaboration of the carers and resource parents.

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • Mathilde LEFEVRE · assistance Publique Hôpitaux de Marseille

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2028-02-29
Completion
2028-02-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06811064 on ClinicalTrials.gov