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

Recruiting

• Conditions: Neurodevelopmental Motor Disorders
• Interventions: Other: Child Neurodevelopment Questionnaires - WP2; Other: Focus group (FC) - WP1; Other: Evaluation of compliance for the acquired skills in terms of development support - WP2; Other: Evaluation of physiotherapist satisfaction with the follow-up and the time spent at the consultation - WP2; Other: 4 Focus Group (FC) - WP2

• Registration Number: NCT05457569
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-13
• Study First Posted: 2022-07-14
• Study Start: 2023-01-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Physiotherapist in a private practice - WP2	Child Neurodevelopment Questionnaires - WP2	Physiotherapists working in a private practice
Physiotherapist in a private practice - WP2	4 Focus Group (FC) - WP2	Physiotherapists working in a private practice
Parents of infants at a high risk of neurodevelopmental disorders - WP1	Focus group (FC) - 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
Parents of children with developmental difficulties - WP1	Focus group (FC) - 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
Health Professionals - WP1	Focus group (FC) - 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.
Physiotherapist in a private practice - WP2	Evaluation of physiotherapist satisfaction with the follow-up and the time spent at the consultation - WP2	Physiotherapists working in a private practice
PMI-CAMPS - WP2	4 Focus Group (FC) - 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.
Parent Support Group - WP1	Focus group (FC) - WP1	Group representatives (SOS Préma, The Neurogroup...)
Physiotherapist in a private practice - WP2	Evaluation of compliance for the acquired skills in terms of development support - WP2	Physiotherapists working in a private practice
Parents - WP2	4 Focus Group (FC) - 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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chu Dijon Bourgogne; 🇫🇷 Dijon, France