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)

University Hospital Center (CHU) Dijon Bourgogne

Status: Enrolling

Conditions: Neurodevelopmental Motor Disorders

Treatments: Other: Focus group (FC) - WP1; Other: 4 Focus Group (FC) - WP2; 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: Child Neurodevelopment Questionnaires - WP2

Study type: Observational

Funder types: Other

Identifiers

NCT05457569

JANDET ReSPIr 2021

Details and patient eligibility

About

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

88 participants in 7 patient groups

Parent Support Group - WP1

Description:

Group representatives (SOS Préma, The Neurogroup...)

Treatment:

Other: Focus group (FC) - WP1

Parents of infants at a high risk of neurodevelopmental disorders - WP1

Description:

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

Treatment:

Other: Focus group (FC) - WP1

Parents of children with developmental difficulties - WP1

Description:

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

Treatment:

Other: Focus group (FC) - WP1

Health Professionals - WP1

Description:

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.

Treatment:

Other: Focus group (FC) - WP1

Physiotherapist in a private practice - WP2

Description:

Physiotherapists working in a private practice

Treatment:

Other: Child Neurodevelopment Questionnaires - WP2

Other: Evaluation of physiotherapist satisfaction with the follow-up and the time spent at the consultation - WP2

Other: Evaluation of compliance for the acquired skills in terms of development support - WP2

Other: 4 Focus Group (FC) - WP2

Parents - WP2

Description:

parents of hospitalized children between 34 weeks of gestation and 4 months of corrected age with at least one risk factor for neurodevelopmental disorder

Treatment:

Other: 4 Focus Group (FC) - WP2

PMI-CAMPS - WP2

Description:

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.

Treatment:

Other: 4 Focus Group (FC) - WP2