Status:
NOT_YET_RECRUITING
Study of the Interprofessional Reproducibility of a Clinical Observation Scale for the Development of Very Premature Infants
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Prematurity
Eligibility:
All Genders
1-6 years
Brief Summary
The research concerns the study of the interprofessional reproducibility of a grid for observing the development of premature infants from 1 to 6 months corrected age. No tool is available to characte...
Detailed Description
Improving the development of premature babies is a challenge. Developmental disabilities are common. Brain damage accounts for only a small proportion of disorders. Other factors have a major influenc...
Eligibility Criteria
Inclusion
- Male or female child born between 27 and 32 weeks of amenorrhea in a singleton pregnancy;
- Child hospitalized in the neonatology unit of Toulouse University Hospital;
- Family home within a 15 km radius of Toulouse to allow for home visits for filming;
- Parents with parental authority affiliated with a social security scheme or equivalent;
- Signature of the informed consent form by the parents with parental authority
- Absence of serious illness, as defined in the exclusion criteria;
- The child may participate in another study during the duration of this study, without an exclusion period.
Exclusion
- Child with a severe organic pathology detected during hospitalization and requiring specific and appropriate care for the diagnosed pathology;
- Child with a neurological complication: Grade 3 or 4 intraventricular hemorrhage, periventricular cavitary leukomalacia, excluding frontal leukomalacia;
- Child with a malformation or multiple malformations that impair the neurological prognosis;
- Child with genetic or metabolic diseases;
- Fetal alcohol syndrome;
- Parental authority holders under guardianship, curatorship, or legal protection;
- Any family condition that prevents compliance with the procedures set out in the study protocol, in the opinion of the investigator.
- Family members who do not speak French fluently, in order to ensure understanding of the system and the proposed care.
Key Trial Info
Start Date :
December 22 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT07169110
Start Date
December 22 2025
End Date
December 30 2026
Last Update
December 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Intensive care /neonatology Toulouse Hospital
Toulouse, France, 31000