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

January 31, 2025 updated by: Assistance Publique Hopitaux De Marseille

Resource Parents in Neonatology: Innovative Partnership Practices to Improve Quality of Life After Returning Home

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1008

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Marseille, France, 13015
        • Assistance Publique des Hôpitaux de Marseille (APHM)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

premature newborn

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention of resource parents for parents of hospitalised premature new born
Parents of hospitalised premature new born watch a testimony video pf other parent who experienced hospitalization of their premature new born
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.
without intervention of resource parents for parents of hospitalised premature new born
Parents of hospitalised premature new born do not watch a testimony video of other parent who experienced hospitalization of their premature new born

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the the quality of life of parent with premature child at one year corrected age
Time Frame: At the one year anniversary (12 months corrected age) of the premature child
Questionnaire PedsQL
At the one year anniversary (12 months corrected age) of the premature child

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Mathilde LEFEVRE, Assistance Publique Hopitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2025

Primary Completion (Estimated)

February 29, 2028

Study Completion (Estimated)

February 29, 2028

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A01087-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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