Neurological Fate, Prematurity and Genetic Susceptibility Factors

Completed

• Conditions: Polymorphism, Restriction Fragment Length; Premature; Infertility of Cervical Origin
• Interventions: Other: no intervention

• Registration Number: NCT04298346
• Lead Sponsor: Nantes University Hospital

Brief Summary

This study could help identify aggravating or protective genetic polymorphisms associated with cerebral palsy. Populations of premature babies at different risk of cerebral palsy could thus be individualized with an impact on their monitoring and on the pathophysiological understanding of the processes leading to neurological lesions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-06
• Study Start: 2020-03-09
• Status Verified: 2021-09
• Primary Completion: 2022-03-09
• Study Completion: 2022-03-09
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• children born prematurely at term <34 weeks between 2008 and 2015
• assessed at the age of 2 within the Growing Together Network in Pays de Loire
• parental consent for the collection of data from their child and for intraoral sampling for the search for genetic factors.

Exclusion Criteria

• children who died after the age of 2
• children who refused and / or whose parents refused to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	no intervention	-
Case	no intervention	-

Primary Outcome Measures

Name	Time	Method
Identify a polymorphism associated with the risk of developing cerebral palsy at 2 years in a regional population of premature infants of gestational age <34 weeks gestation.	2 years	frequency of variants within the case and control groups using the statistical criterion "level of significance" (also called p-value and known by the English word "p-value") of 5.10-8

Secondary Outcome Measures

Name	Time	Method
Identify a specific polymorphism of certain forms of cerebral palsy	2 years	neurological examination
Develop a prognosis algorithm for the occurrence of cerebral palsy for personalized monitoring in a population at risk.	2 years	neurological examination

Trial Locations

Locations (1)

CHU Nantes; 🇫🇷 Nantes, France