Complications of PrematurityNEORISNCT02054507
Prematurity Related Risks of Cognitive Impairment at School Age
A study testing Cognitive evaluation (Wechsler IV tests) in people with Complications of Prematurity, run by Jean Michel Hascoet at 2 sites in France.
Trial summary
The main purpose of this study is to better evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to social situation, intra family relationships, and modalities of care. The study will be divided into 3 parts: 1. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Complications of Prematurity
- What is being tested?
- Cognitive evaluation (Wechsler IV tests)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2013to Mar 2015
- Phase
- Interventional
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Former premature infants aged 8-11 years
- School grade appropriate for their age
- Schoolmate control children born at term aged 8-11 years
Who cannot join
- Any neurological sequelae
Trial locations and contacts
2 sites in 1 country.
France2 sites
M.S.H. Lorraine/Lorraine Institue for Social Sciences and Humanities (CNRS, Université de Lorraine)
Nancy, 54001
Maternite Regionale Univesitaire
Nancy, 54035
About this study
Official title: Prematurity Related Risks of Cognitive Impairment at School Age With Regards to Social, Family and Care Environment
The main purpose of this study is to better evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to social situation, intra family relationships, and modalities of care.
The study will be divided into 3 parts:
- Children born prematurely in our level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine cognitive test. The relationships between cognitive scores and neonatal characteristics will be determined and compared to the results of schoolmates born at term.
- The quality of parent and child relationship will be evaluated by a standardized questionnaire allowing the evaluation of persistent stress trauma related to premature birth.
- An anthropologic study of the utilization of care resources will also be performed within the follow-up network taking care of these children.
Read the detailed description
Long term follow-up of vulnerable children such as infants born prematurely are generally studied without taking into account the social, familial and care resources available in the child environment.
Thus, the main purpose of this study is to evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to related social situation, intra family relationships, modalities of care and utilization of care resources.
The study will be divided into 3 parts:
- Children born prematurely in our level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine test (WISC IV). The relationship between cognitive scores and neonatal characteristics will be determined and compared with the results of schoolmate control children, born at term.
- The quality of parent and child relationship will be evaluated by standardized questionnaire (Perinatal PTSD Questionnaire). This questionnaire allows evaluating persistent perinatal stress trauma related to prematurity.
- An anthropologic study of care and utilization of care resources will be performed within the follow-up network taking care of these children. This part will use semi-directive interviews of caregivers involved in the follow-up network.
This study should allow to better correlate prematurely born children outcome with their global environment and propose improvements in care resources utilization for a better development.
- Conditions
- Complications of Prematurity
- Being tested
- Cognitive evaluation (Wechsler IV tests)
- Keywords
- Children, Cognitive outcome, Prematurity, Care Network, Outpatient follow-up of cognitive development, Care resources
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive evaluation (Wechsler IV tests)Behavioural
Children born prematurely in a level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine test (WISC IV). The relationship between cognitive scores and neonatal characteristics will be determined and compared with the results of schoolmate control children, born at term.
| Study group | Role | What they receive |
|---|---|---|
| Former premature infants | No intervention | Cognitive and executive evaluation by Wechsler IV tests Receives: Behavioral: Cognitive evaluation (Wechsler IV tests) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive and executive functions at school age in prematurely born children
Assessment by WECHSLER IV tests of children born prematurely without neurological or sensorial sequelae, and without psychological difficulties; All in school grade appropriate for their ages
Controls : children born at term, matched for age and school grade.
Measured: Children at the age of 8-11 years
Secondary outcomes (1)
Quality of parent and children relationship
Evaluation will be performed by standardized questionnaire (Perinatal PTSD Questionnaire). This questionnaire allows evaluating persistent perinatal stress trauma related to prematurity.
Measured: Evaluated at 8-11 years of children (at the time of child cognitive evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications of PrematurityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean Michel Hascoet
- Sponsor type
- University, hospital or other
- Collaborators
- Maternite Regionale Universitaire
- Responsible party
- Sponsor-investigator, Jean Michel Hascoet, Maternite Regionale Universitaire
- Investigators
- Jean-Michel HASCOET, MD, Principal investigator, Maternite Regionale Universitaire CHU NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02054507
- Sponsor's protocol ID
- MRU.10.11
- Other IDs
- NEORIS
- Acronym
- NEORIS
- Status last verified
- Apr 2015
- First submitted
- 27 Jan 2014
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prematurity Related Risks of Cognitive Impairment at School Age With Regards to Social, Family and Care Environment
- ClinicalTrials.gov ID
- NCT02054507
- Acronym / sponsor ID
- NEORIS / MRU.10.11
- Conditions
- Complications of Prematurity
- Keywords
- Children, Cognitive outcome, Prematurity, Care Network, Outpatient follow-up of cognitive development, Care resources
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jean Michel HascoetUniversity, hospital or other
- Collaborators
- Maternite Regionale Universitaire
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Feb 2014 (estimated)
- 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.
The main purpose of this study is to better evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to social situation, intra family relationships, and modalities of care.
The study will be divided into 3 parts:
- Children born prematurely in our level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine cognitive test. The relationships between cognitive scores and neonatal characteristics will be determined and compared to the results of schoolmates born at term.
- The quality of parent and child relationship will be evaluated by a standardized questionnaire allowing the evaluation of persistent stress trauma related to premature birth.
- An anthropologic study of the utilization of care resources will also be performed within the follow-up network taking care of these children.
Detailed description
Long term follow-up of vulnerable children such as infants born prematurely are generally studied without taking into account the social, familial and care resources available in the child environment.
Thus, the main purpose of this study is to evaluate prematurely born children cognitive development at school age, with regards to birth conditions but also to related social situation, intra family relationships, modalities of care and utilization of care resources.
The study will be divided into 3 parts:
- Children born prematurely in our level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine test (WISC IV). The relationship between cognitive scores and neonatal characteristics will be determined and compared with the results of schoolmate control children, born at term.
- The quality of parent and child relationship will be evaluated by standardized questionnaire (Perinatal PTSD Questionnaire). This questionnaire allows evaluating persistent perinatal stress trauma related to prematurity.
- An anthropologic study of care and utilization of care resources will be performed within the follow-up network taking care of these children. This part will use semi-directive interviews of caregivers involved in the follow-up network.
This study should allow to better correlate prematurely born children outcome with their global environment and propose improvements in care resources utilization for a better development.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Former premature infants | No intervention | Behavioral: Cognitive evaluation (Wechsler IV tests)Cognitive and executive evaluation by Wechsler IV tests |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Former premature infants aged 8-11 years
- School grade appropriate for their age
- Schoolmate control children born at term aged 8-11 years
Key exclusion criteria (1 listed)
- Any neurological sequelae
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 |
|---|---|---|
| Cognitive evaluation (Wechsler IV tests)Children born prematurely in a level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine test (WISC IV). The relationship between cognitive scores and neonatal characteristics will be determined and compared with the results of schoolmate control children, born at term. | Behavioural | Former premature infants |
Primary outcome
Cognitive and executive functions at school age in prematurely born children
Time frame: Children at the age of 8-11 years
Assessment by WECHSLER IV tests of children born prematurely without neurological or sensorial sequelae, and without psychological difficulties; All in school grade appropriate for their ages Controls : children born at term, matched for age and school grade.
1 secondary outcome
Quality of parent and children relationship
Time frame: Evaluated at 8-11 years of children (at the time of child cognitive evaluation)
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 8 Apr 2015.
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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.
Jean-Michel HASCOET, MD principal investigator
Maternite Regionale Universitaire CHU NANCY
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive evaluation (Wechsler IV tests) in people with Complications of Prematurity, run by Jean Michel Hascoet at 2 sites 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 1 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 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Cognitive and executive functions at school age in prematurely born children (time frame: Children at the age of 8-11 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 8 Apr 2015.