Neurological Fate, Prematurity and Genetic Susceptibility Factors

Premature Clinical Trial

— GENIMOC  

Official title:

GENIMOC : Neurological Fate, Prematurity and Genetic Susceptibility Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04298346
• Other study ID #: RC19_0035
• Status: Completed
• Start date: March 9, 2020
• Est. completion date: March 9, 2022

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 9, 2022
• Est. primary completion date: March 9, 2022
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Genetic Predisposition to Disease
• Infertility
• Infertility of Cervical Origin
• Polymorphism, Restriction Fragment Length
• Premature

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
France	CHU Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	2 years
Secondary	Identify a specific polymorphism of certain forms of cerebral palsy	neurological examination	2 years
Secondary	Develop a prognosis algorithm for the occurrence of cerebral palsy for personalized monitoring in a population at risk.	neurological examination	2 years