Neurological Fate, Prematurity and Genetic Susceptibility Factors
GENIMOC
GENIMOC : Neurological Fate, Prematurity and Genetic Susceptibility Factors
1 other identifier
observational
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 6, 2020
CompletedStudy Start
First participant enrolled
March 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2022
CompletedAugust 4, 2023
September 1, 2021
2 years
March 2, 2020
August 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (2)
Case
Control
Interventions
Eligibility Criteria
Children born prematurely at term \<34 weeks between 2008 and 2015, and presenting with cerebral palsy at the age of 2 years within the Growing Together Network in Pays de Loire. Matching by a propensity score to a population of control children with a comparable probability of developing cerebral palsy but whose examination at 2 years is optimal
You may qualify if:
- 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.
You may not qualify if:
- children who died after the age of 2
- children who refused and / or whose parents refused to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Nantes
Nantes, 44000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2020
First Posted
March 6, 2020
Study Start
March 9, 2020
Primary Completion
March 9, 2022
Study Completion
March 9, 2022
Last Updated
August 4, 2023
Record last verified: 2021-09