GENIMOC : Neurological Fate, Prematurity and Genetic Susceptibility Factors

Nantes University Hospital1 site in 1 country27 target enrollmentMarch 9, 2020

ConditionsPremature Polymorphism, Restriction Fragment Length Infertility of Cervical Origin

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Premature
Sponsor: Nantes University Hospital
Enrollment: 27
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 9, 2020

End Date

March 9, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Nantes University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: 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 Outcomes

Identify a specific polymorphism of certain forms of cerebral palsy(2 years)
Develop a prognosis algorithm for the occurrence of cerebral palsy for personalized monitoring in a population at risk.(2 years)