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OpenTrials
Completed

NCT Number: NCT04298346

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.

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Key information

Conditions

Polymorphism, Restriction Fragment Length Female Urogenital Diseases and Pregnancy Complications Infertility of Cervical Origin Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Premature Birth Urogenital Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nantes

Nantes, 44000, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

no intervention

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.

    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

  1. Identify a specific polymorphism of certain forms of cerebral palsy

    Time frame: 2 years

    neurological examination

  2. Develop a prognosis algorithm for the occurrence of cerebral palsy for personalized monitoring in a population at risk.

    Time frame: 2 years

    neurological examination

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

GENIMOC : Neurological Fate, Prematurity and Genetic Susceptibility Factors

Acronym: GENIMOC

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 6, 2020
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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