Neurodevelopmental Motor DisordersPRéPaRNCT05457569
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 of Neurodevelopmental Motor Disorders, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurodevelopmental Motor Disorders
- What is being tested?
- Focus group (FC) - WP1, Child Neurodevelopment Questionnaires - WP2 and Evaluation of compliance for the acquired skills in terms of development support - WP2
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2023to Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parents of infants at high risk of neurodevelopmental disorders Parents of children with developmental disorders
Who may be able to join
- 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
Show all 28Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Sandrine JANDET CARRON, 0672089035, sandrine.jandet@gmail.com
Sébastien KRUMM, 0380669032, sebastien.krumm@chu-dijon.fr
About this study
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.
- Conditions
- Neurodevelopmental Motor Disorders
- Being tested
- Focus group (FC) - WP1, Child Neurodevelopment Questionnaires - WP2, Evaluation of compliance for the acquired skills in terms of development support - WP2, Evaluation of physiotherapist satisfaction with the follow-up and the time spent at the consultation - WP2, 4 Focus Group (FC) - WP2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus group (FC) - WP1Other
3 group meetings for each group of parents:
- Parents only
- Parents and representatives of patient support groups
- Parents and health professionals specialized in the care of these children at risk
Child Neurodevelopment Questionnaires - WP2Other
during the 4th month of corrected infant age
Evaluation of compliance for the acquired skills in terms of development support - WP2Other
during the 4th month of corrected infant age
Evaluation of physiotherapist satisfaction with the follow-up and the time spent at the consultation - WP2Other
at the end of the study
4 Focus Group (FC) - WP2Other
- Parents who accepted the follow-up
- Parents who have partially completed the programme
- Maternal and Child Protection \& CAMSP professionals
- Physiotherapists in a private practice
| Study group | Role | What they receive |
|---|---|---|
| Parent Support Group - WP1 | Group representatives (SOS Préma, The Neurogroup...) Receives: 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 Receives: 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 Receives: 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. Receives: Other: Focus group (FC) - WP1 | |
| Physiotherapist in a private practice - WP2 | Physiotherapists working in a private practice Receives: 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 Receives: 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. Receives: Other: 4 Focus Group (FC) - WP2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Typology, categorization and operationalization of parental needs and expectations
These will be used to develop of the early education program
Measured: Through WP1 completion an average of 18 months
Typology of perceived subjective representations and description of barriers and levers to use with parents and professionals
Measured: through WP2 completion an average of 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start9 Jan 2023
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental Motor DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457569
- Sponsor's protocol ID
- JANDET ReSPIr 2021
- Acronym
- PRéPaR
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2022
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fromion C, Krumm S, Jandet S, Ksiazek E, Gueugnon M, Ornetti P, Meunier-Beillard N, Fournel I. Acceptability and feasibility of a community-hospital parenting support and prevention programme for families of infants at high neurodevelopmental risk following neonatal encephalopathy: protocol of the PRePaR (PRevention and support for Parenthood in early Rehabilitation) mixed-methods study. BMJ Open. 2026 Mar 12;16(3):e110673. doi: 10.1136/bmjopen-2025-110673.
PubMed 41819586
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05457569
- Acronym / sponsor ID
- PRéPaR / JANDET ReSPIr 2021
- Conditions
- Neurodevelopmental Motor Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 14 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Parent Support Group - WP1 | – | Other: Focus group (FC) - WP1Group representatives (SOS Préma, The Neurogroup...) |
| Parents of infants at a high risk of neurodevelopmental disorders - WP1 | – | Other: Focus group (FC) - WP1infants 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 | – | Other: Focus group (FC) - WP1children 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 | – | Other: Focus group (FC) - WP1Private 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 | – | 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) - WP2Physiotherapists working in a private practice |
| Parents - WP2 | – | Other: 4 Focus Group (FC) - WP2parents of hospitalized children between 34 weeks of gestation and 4 months of corrected age with at least one risk factor for neurodevelopmental disorder |
| PMI-CAMPS - WP2 | – | Other: 4 Focus Group (FC) - WP2Labor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parents of infants at high risk of neurodevelopmental disorders Parents of children with developmental disorders
Key inclusion criteria (28 listed)
- For the group of parents of children with documented neurodevelopmental difficulties, their child must meet the following three conditions:
- 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:
- The parents must be able to participate in the 3 interviews (T1, T2 and T3).
- Professionals and parent support groups:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus group (FC) - WP13 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 | Other | Health Professionals - WP1, Parent Support Group - WP1, Parents of children with developmental difficulties - WP1, Parents of infants at a high risk of neurodevelopmental disorders - WP1 |
| Child Neurodevelopment Questionnaires - WP2during the 4th month of corrected infant age | Other | Physiotherapist in a private practice - WP2 |
| Evaluation of compliance for the acquired skills in terms of development support - WP2during the 4th month of corrected infant age | Other | Physiotherapist in a private practice - WP2 |
| Evaluation of physiotherapist satisfaction with the follow-up and the time spent at the consultation - WP2at the end of the study | Other | Physiotherapist in a private practice - WP2 |
| 4 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 | Other | PMI-CAMPS - WP2, Parents - WP2, Physiotherapist in a private practice - WP2 |
Primary outcome
Typology, categorization and operationalization of parental needs and expectations
Time frame: 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
Time frame: through WP2 completion an average of 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Derived from this study: PubMed 41819586Fromion C, Krumm S, Jandet S, Ksiazek E, Gueugnon M, Ornetti P, Meunier-Beillard N, Fournel I. Acceptability and feasibility of a community-hospital parenting support and prevention programme for families of infants at high neurodevelopmental risk following neonatal encephalopathy: protocol of the PRePaR (PRevention and support for Parenthood in early Rehabilitation) mixed-methods study. BMJ Open. 2026 Mar 12;16(3):e110673. doi: 10.1136/bmjopen-2025-110673.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Motor Disorders, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandrine JANDET CARON (0672089035, sandrine.jandet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Typology, categorization and operationalization of parental needs and expectations (time frame: Through WP1 completion an average of 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05457569, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.