Acceptability and Feasibility of Implementing a Coordinated Hospital/Non-hospital Parenting Support and Prevention Program for Families of Infants at High Neurodevelopmental Risk After Neonatal Intensive Care Hospitalization (PRéPaR)

February 7, 2024 updated by: Centre Hospitalier Universitaire Dijon
The PRéPaR project aims to construct, with the help of parents and early care providers, a support program for the families of infants at an increased risk for neurodevelopmental disorders, and to evaluate the acceptability and feasibility of such a program. This program aims to strengthen parenting skills, support infant development and improve the continuity of hospital/non-hospital care, including early identification of neurodevelopmental motor disorders and continuation of the support initiated during neonatal hospitalization.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

88

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 Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Parents of infants at high risk of neurodevelopmental disorders Parents of children with developmental disorders

Description

Inclusion Criteria:

WP1:

  1. For the group of parents of children with documented neurodevelopmental difficulties, their child must meet the following three conditions:

    • Be between 18 months and 48 months corrected age at the time of the first focus group

    • Have at least one risk factor putting them at high neurodevelopmental risk at birth:

      • Preterm infant ≤ 31 WG + 6 days
      • Birth weight less than 1500g
      • Child who has had a stroke or stages 2 or 3 hypoxic-ischaemic encephalopathy of the newborn according to the Sarnat classification
      • Central neurological lesion, diagnosed on brain imaging.
    • Present an abnormal, non-transient clinical state: diagnosis of cerebral palsy made or in progress (GMFCS 1 to 5), central neurological syndrome, diagnosed neurodevelopmental disorder.

    The parents must be able to participate in the 3 interviews (T1, T2 and T3).

  2. For the group of infants at high neurodevelopmental risk at hospital discharge, their child must meet the following two conditions:

    • Be between 34 weeks of amenorrhea (i.e., 1.5 months premature) and 12 months of corrected age at the time of the first focus group,

    • Have at least one risk factor putting them at high neurodevelopmental risk at birth:

      • Preterm infant ≤ 31 WG + 6 days
      • Birth weight less than 1500g
      • Child who has had a stroke or stages 2 or 3 hypoxic-ischaemic encephalopathy of the newborn according to the Sarnat classification
      • Central neurological lesion, diagnosed on brain imaging.

    The parents must be able to participate in the 3 interviews (T1, T2 and T3).

  3. Professionals and parent support groups:

Physiotherapists in private practice, labor and delivery nurses of the Maternal and Child Protection, CAMSP (psychomotricians, psychologists) and doctors involved in the care of children at developmental risk in charge of the follow-up of children for whom the parents have agreed to participate in the study. These professionals must in turn have agreed to participate in the study. User representatives (SOS Préma, Le Neurogroup...) who have agreed to participate in the study.

WP2:

  1. Parents of children hospitalized in the neonatal services of the CHU Dijon who meet at least one of the following criteria:

    • Be between 34 weeks of amenorrhea (1.5 months premature) and 3 months of corrected age (3 months post-term)

    • Have at least one risk factor putting them at high neurodevelopmental risk at birth:

      • Child who has had a stroke or stages 2 or 3 hypoxic-ischaemic encephalopathy of the newborn according to the Sarnat classification
      • Central neurological lesion, diagnosed on brain imaging.
  2. Professionals:

Physiotherapists in private practice, labor and delievery nurses of the Maternal and Child Protection, CAMSP (psychomotricians, psychologists) and physicians involved in the care of children at developmental risk in charge of the follow-up of the children whose parents agreed to participate in the study. These professionals must in turn have agreed to participate in the study.

Exclusion Criteria:

  • Parents who are physically or cognitively unable to participate in a group interview or who do not have a sufficient command of French.
  • Parents who are minors
  • Parents under legal protection
  • Parents of children with major orthopedic or traumatic disorders unrelated to the high risk of cerebral palsy.

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
Parent Support Group - WP1
Group representatives (SOS Préma, The Neurogroup...)
Other: Focus group (FC) - WP1

3 group meetings for each group of parents:

  1. Parents only
  2. Parents and representatives of patient support groups
  3. Parents and health professionals specialized in the care of these children at risk
Parents of infants at a high risk of neurodevelopmental disorders - WP1
infants between 34 weeks' gestation and 4 months' corrected age at the time of the first focus group and with at least one risk factor for neurodevelopmental disorder
Other: Focus group (FC) - WP1

3 group meetings for each group of parents:

  1. Parents only
  2. Parents and representatives of patient support groups
  3. Parents and health professionals specialized in the care of these children at risk
Parents of children with developmental difficulties - WP1

children between 18 and 48 months corrected age at the time of the first focus group:

  • with at least one risk factor for neurodevelopmental disorder
  • presenting an abnormal, non-transient clinical state
Other: Focus group (FC) - WP1

3 group meetings for each group of parents:

  1. Parents only
  2. Parents and representatives of patient support groups
  3. Parents and health professionals specialized in the care of these children at risk
Health Professionals - WP1
Private physiotherapists, labor and delivery nurses of the Maternal and Child Protection, Centre d'action médico-sociale précoce (CAMSP) (psychomotricians, psychologists) and doctors involved in the care and follow up of children at risk of developmental disorders whose parents have agreed to participate in the study.
Other: Focus group (FC) - WP1

3 group meetings for each group of parents:

  1. Parents only
  2. Parents and representatives of patient support groups
  3. Parents and health professionals specialized in the care of these children at risk
Physiotherapist in a private practice - WP2
Physiotherapists working in a private practice
Other: Child Neurodevelopment Questionnaires - WP2
during the 4th month of corrected infant age
Other: Evaluation of compliance for the acquired skills in terms of development support - WP2
during the 4th month of corrected infant age
Other: Evaluation of physiotherapist satisfaction with the follow-up and the time spent at the consultation - WP2
at the end of the study
Other: 4 Focus Group (FC) - WP2
  • Parents who accepted the follow-up
  • Parents who have partially completed the programme
  • Maternal and Child Protection & CAMSP professionals
  • Physiotherapists in a private practice
Parents - WP2
parents of hospitalized children between 34 weeks of gestation and 4 months of corrected age with at least one risk factor for neurodevelopmental disorder
Other: 4 Focus Group (FC) - WP2
  • Parents who accepted the follow-up
  • Parents who have partially completed the programme
  • Maternal and Child Protection & CAMSP professionals
  • Physiotherapists in a private practice
PMI-CAMPS - WP2
Labor and delivery nurses from the Protection Maternelle et Infantile, CAMPS (psychomotricians, psychologists) and doctors involved in the care of children at risk of developmental disorders who are in charge of the follow-up of children whose parents have agreed to participate in the study.
Other: 4 Focus Group (FC) - WP2
  • Parents who accepted the follow-up
  • Parents who have partially completed the programme
  • Maternal and Child Protection & CAMSP professionals
  • Physiotherapists in a private practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Typology, categorization and operationalization of parental needs and expectations
Time Frame: Through WP1 completion an average of 18 months
These will be used to develop of the early education program
Through WP1 completion an average of 18 months
Typology of perceived subjective representations and description of barriers and levers to use with parents and professionals
Time Frame: through WP2 completion an average of 16 months
through WP2 completion an average of 16 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

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 (Actual)

January 9, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 14, 2022

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JANDET ReSPIr 2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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