Program to support families of infants at high risk for neurodevelopmental disorders

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

This study is testing a new support program for families with infants at high risk for developmental issues to see if it helps them improve parenting skills and get the care they need after leaving the hospital.

Quick facts

• Study type: Observational
• Enrollment: 88 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire Dijon (Academic / other)
• Locations: 1 site (Dijon)
• Trial ID: NCT05457569 on ClinicalTrials.gov

What this trial studies

The PRéPaR project aims to develop a coordinated support program for families of infants who are at high risk for neurodevelopmental disorders following their stay in neonatal intensive care. This observational study will involve focus groups and questionnaires to evaluate the program's acceptability and feasibility, focusing on enhancing parenting skills and ensuring continuity of care. The program seeks to identify neurodevelopmental motor disorders early and provide ongoing support to families. Parents will participate in multiple interviews to share their experiences and feedback on the program.

Who should consider this trial

Good fit: Ideal candidates include parents of infants aged 18 to 48 months who have documented neurodevelopmental difficulties or are at high neurodevelopmental risk due to specific medical conditions.

Not a fit: Patients who do not have infants at high neurodevelopmental risk or those who cannot participate in the required interviews may not benefit from this program.

Why it matters

Potential benefit: If successful, this program could significantly improve parenting skills and developmental outcomes for infants at high risk for neurodevelopmental disorders.

How similar studies have performed: While there may be similar programs, this specific approach to coordinated hospital/non-hospital support for high-risk infants is relatively novel.

Eligibility criteria

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.

Where this trial is running

Dijon

• Chu Dijon Bourgogne — Dijon, France (Recruiting)

Study contacts

• Study coordinator: Sandrine JANDET CARON

Conditions Neurodevelopmental Motor Disorders