Neurological Fate, Prematurity and Genetic Susceptibility Factors (GENIMOC)

August 3, 2023 updated by: Nantes University Hospital

GENIMOC : Neurological Fate, Prematurity and Genetic Susceptibility Factors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44000
        • CHU Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Other: no intervention
no intervention
Case
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify a specific polymorphism of certain forms of cerebral palsy
Time Frame: 2 years
neurological examination
2 years
Develop a prognosis algorithm for the occurrence of cerebral palsy for personalized monitoring in a population at risk.
Time Frame: 2 years
neurological examination
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2020

Primary Completion (Actual)

March 9, 2022

Study Completion (Actual)

March 9, 2022

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 6, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC19_0035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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