Premature BirthNCT06731686
Single-center Retrospective Study : Developmental Trajectories of Children Born Prematurely Before 32 Weeks Assessed With the Revised Brunet Lézine Scale at 1, 2 and 3 Years
An observational study of Premature Birth, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
This study will assess professionals in the CHI Créteil neonatal department and the Val de Marne perinatal network to gain a better understanding of the developmental trajectories of children hospitalized at the CHI Créteil, with a view to optimizing their care in the long term Read more about this study
- Who is it for?
- Ages 2 to 32 months
- Conditions the study is for
- Premature Birth
- What is being tested?
- Retrospective study
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 23 Nov 2023to 17 Jun 2024
- 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 2 to 32 months
- All sexes
- No healthy volunteers
- Child
Study population: Children born prematurely before 32 weeks
Who may be able to join
- Children born at CHI Créteil between 2012 and 2022, included in the Val de Marne perinatal network.
- Children seen in pediatrician-psychomotor consultation with assessment by the BLR scale at 1 year AC.
Who cannot join
- Children born with a term of birth ≥ 32 weeks + 1 day.
- Child removed from the Val de Marne perinatal network monitoring from the age of 1 year AC: Death or parental decision.
- Children presenting with cerebral palsy, blindness or deafness at the age of 1 year AC.
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess professionals in the CHI Créteil neonatal department and the Val de Marne perinatal network to gain a better understanding of the developmental trajectories of children hospitalized at the CHI Créteil, with a view to optimizing their care in the long term
- Conditions
- Premature Birth
- Being tested
- Retrospective study
- Keywords
- Developmental trajectories, Revised Brunet Lézine, movement and posture, language, socialization, coordination
- Medical subject headings
- Premature Birth, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective studyOther
Collection of children's datas
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall DQ obtained on the BLR scale at 1, 2 and 3 years, collected by the psychomotor therapists at CHI Créteil.
Measured: 1, 2 and 3 years
Secondary outcomes (8)
Analysis of the 4 sub-scores (movement and posture, language, socialization, coordination) obtained on the BLR scale at 1, 2 and 3 years, collected by the psychomotor therapists at CHI Créteil.
Measured: 1,2 and 3 years
Analysis of family socio-demographic data : level of education
Measured: 1,2 and 3 years
Analysis of family socio-demographic data : age of parents
Measured: 1,2 and 3 years
Analysis of birth data : term
Measured: 1, 2 and 3 years
Analysis of birth data : weight
Measured: 1,2 and 3 years
Analysis of duration of hospitalization
Measured: 1,2 and 3 years
Evaluate the concordance of BLR scale at 5 years with the measurement scores (not validated) used by the Val de Marne perinatal network (and all the Ile de France perinatal networks) filed out during the same consultations
Measured: 5 years
Evaluate the concordance of BLR scale at 5 years with the measurement scores (not validated) used by the Val de Marne perinatal network (and all the Ile de France perinatal networks) filed out during the same consultations
Measured: 1,2 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start23 Nov 2023
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731686
- Sponsor's protocol ID
- PREMADEV
- Status last verified
- Dec 2024
- First submitted
- 25 Mar 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Retrospective Study : Developmental Trajectories of Children Born Prematurely Before 32 Weeks Assessed With the Revised Brunet Lézine Scale at 1, 2 and 3 Years
- ClinicalTrials.gov ID
- NCT06731686
- Acronym / sponsor ID
- PREMADEV
- Conditions
- Premature Birth
- Keywords
- Developmental trajectories, Revised Brunet Lézine, movement and posture, language, socialization, coordination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 12 Dec 2024 (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 will assess professionals in the CHI Créteil neonatal department and the Val de Marne perinatal network to gain a better understanding of the developmental trajectories of children hospitalized at the CHI Créteil, with a view to optimizing their care in the long term
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 2 to 32 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children born prematurely before 32 weeks
Key inclusion criteria (2 listed)
- Children born at CHI Créteil between 2012 and 2022, included in the Val de Marne perinatal network.
- Children seen in pediatrician-psychomotor consultation with assessment by the BLR scale at 1 year AC.
Key exclusion criteria (3 listed)
- Children born with a term of birth ≥ 32 weeks + 1 day.
- Child removed from the Val de Marne perinatal network monitoring from the age of 1 year AC: Death or parental decision.
- Children presenting with cerebral palsy, blindness or deafness at the age of 1 year AC.
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 |
|---|---|---|
| Retrospective studyCollection of children's datas | Other | – |
Primary outcome
Overall DQ obtained on the BLR scale at 1, 2 and 3 years, collected by the psychomotor therapists at CHI Créteil.
Time frame: 1, 2 and 3 years
8 secondary outcomes
Analysis of the 4 sub-scores (movement and posture, language, socialization, coordination) obtained on the BLR scale at 1, 2 and 3 years, collected by the psychomotor therapists at CHI Créteil.
Time frame: 1,2 and 3 years
Analysis of family socio-demographic data : level of education
Time frame: 1,2 and 3 years
Analysis of family socio-demographic data : age of parents
Time frame: 1,2 and 3 years
Analysis of birth data : term
Time frame: 1, 2 and 3 years
Analysis of birth data : weight
Time frame: 1,2 and 3 years
Analysis of duration of hospitalization
Time frame: 1,2 and 3 years
Evaluate the concordance of BLR scale at 5 years with the measurement scores (not validated) used by the Val de Marne perinatal network (and all the Ile de France perinatal networks) filed out during the same consultations
Time frame: 5 years
Evaluate the concordance of BLR scale at 5 years with the measurement scores (not validated) used by the Val de Marne perinatal network (and all the Ile de France perinatal networks) filed out during the same consultations
Time frame: 1,2 and 3 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 12 Dec 2024.
- Individual participant dataSharing planned: No
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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 Premature Birth, run by Centre Hospitalier Intercommunal Creteil 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 2 inclusion and 3 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 12 Dec 2024. 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?
Overall DQ obtained on the BLR scale at 1, 2 and 3 years, collected by the psychomotor therapists at CHI Créteil. (time frame: 1, 2 and 3 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 12 Dec 2024.