Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT05457569
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05457569
Study Brief:
Protocol Section:
NCT05457569