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RecruitingNCT05457569PRéPaRUpdated Jul 22, 2024

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

An observational study in Neurodevelopmental Motor Disorders, sponsored by Centre Hospitalier Universitaire Dijon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-22.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
88
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Neurodevelopmental Motor Disorders

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03

In context

Motor Disorders

78 studies on the registry are indexed under Motor Disorders; 26 are open to participants now.

This study's planned enrollment of 88 is above the median of 70 across 23 observational studies indexed under Motor Disorders.

Browse Motor Disorders studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
88 participants (estimated)
Patient registry
No

Groups and cohorts

  • Parent Support Group - WP1

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

    Other: Focus group (FC) - WP1

  • 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

  • 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

  • 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

  • Physiotherapist in a private practice - WP2

    Physiotherapists working in a private practice

    Other: Child Neurodevelopment Questionnaires - 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: 4 Focus Group (FC) - WP2

  • 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

  • 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

Interventions

  • OtherFocus 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

  • OtherChild Neurodevelopment Questionnaires - WP2

    during the 4th month of corrected infant age

  • OtherEvaluation of compliance for the acquired skills in terms of development support - WP2

    during the 4th month of corrected infant age

  • OtherEvaluation of physiotherapist satisfaction with the follow-up and the time spent at the consultation - WP2

    at the end of the study

  • Other4 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

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What researchers measure

Primary outcomes

  1. Typology, categorization and operationalization of parental needs and expectations

    These will be used to develop of the early education program

    Time frame: Through WP1 completion an average of 18 months

  2. 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

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05457569
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Jul 14, 2022
Start date
Jan 9, 2023
Primary completion
Nov 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Jul 22, 2024

Study contacts

Sandrine JANDET CARON
Contact
sandrine.jandet@gmail.com
0672089035

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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