Polymorphism, Restriction Fragment LengthGENIMOCNCT04298346
Neurological Fate, Prematurity and Genetic Susceptibility Factors
An observational study of Polymorphism, Restriction Fragment Length and Premature, run by Nantes University Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Polymorphism, Restriction Fragment Length, Premature, Infertility of Cervical Origin
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2020to 9 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Child
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
Who may be able to join
- 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.
Who cannot join
- children who died after the age of 2
- children who refused and / or whose parents refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- no intervention
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Case | Not described Receives: Other: no intervention | |
| Control | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (2)
Identify a specific polymorphism of certain forms of cerebral palsy
neurological examination
Measured: 2 years
Develop a prognosis algorithm for the occurrence of cerebral palsy for personalized monitoring in a population at risk.
neurological examination
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start9 Mar 2020
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymorphism, Restriction Fragment LengthStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298346
- Sponsor's protocol ID
- RC19_0035
- Acronym
- GENIMOC
- Status last verified
- Sep 2021
- First submitted
- 2 Mar 2020
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GENIMOC : Neurological Fate, Prematurity and Genetic Susceptibility Factors
- ClinicalTrials.gov ID
- NCT04298346
- Acronym / sponsor ID
- GENIMOC / RC19_0035
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: no intervention |
| Control | – | Other: no intervention |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- children who died after the age of 2
- children who refused and / or whose parents refused to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Case, Control |
Primary outcome
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 secondary outcomes
Identify a specific polymorphism of certain forms of cerebral palsy
Time frame: 2 years
Develop a prognosis algorithm for the occurrence of cerebral palsy for personalized monitoring in a population at risk.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polymorphism, Restriction Fragment Length and Premature, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.