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
NCT ID: NCT05457569
Last Updated: 2024-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
88 participants
OBSERVATIONAL
2023-01-09
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Parent Support Group - WP1
Group representatives (SOS Préma, The Neurogroup...)
Focus 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
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
Focus 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
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
Focus 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
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.
Focus 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
Physiotherapist in a private practice - WP2
Physiotherapists working in a private practice
Child Neurodevelopment Questionnaires - WP2
during the 4th month of corrected infant age
Evaluation of compliance for the acquired skills in terms of development support - WP2
during the 4th month of corrected infant age
Evaluation of physiotherapist satisfaction with the follow-up and the time spent at the consultation - WP2
at the end of the study
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
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
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
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.
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
Interventions
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Focus 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
Child Neurodevelopment Questionnaires - WP2
during the 4th month of corrected infant age
Evaluation of compliance for the acquired skills in terms of development support - WP2
during the 4th month of corrected infant age
Evaluation of physiotherapist satisfaction with the follow-up and the time spent at the consultation - WP2
at the end of the study
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
Eligibility Criteria
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Inclusion Criteria
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 minors
* Parents under legal protection
* Parents of children with major orthopedic or traumatic disorders unrelated to the high risk of cerebral palsy.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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Chu Dijon Bourgogne
Dijon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JANDET ReSPIr 2021
Identifier Type: -
Identifier Source: org_study_id
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