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

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Description

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

Start Date
January 9, 2023
Completion Date
November 1, 2025
Enrollment
88
Date Posted
July 14, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Chu Dijon Bourgogne
Dijon 21000, France

Eligibility

Study Population
Parents of infants at high risk of neurodevelopmental disorders Parents of children with developmental disorders
Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

WP1:

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).

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).

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:

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.
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 Contact Info

Study Contact Name
Sandrine JANDET CARON
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05457569