CHILDREN BORN VERY PRETERM AT SCHOOL-AGENCT01675726
QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
A study testing questionary on quality of life in people with CHILDREN BORN VERY PRETERM AT SCHOOL-AGE, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born very preterm (<28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the QoL reported by a French general population of reference. Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
- What is being tested?
- questionary on quality of life
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Aug 2017
- 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 7 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child been born between 01/01/2005 and the inclusive 31/12/2007,
- Extreme premature born Child before 28 weeks of amenorrhea,
- Child hospitalized after the birth in a level maternity 3 (been born " inborn " or " outborn ")
- Not dead Child,
- Child not presenting a cerebral palsy,
- Child capable of answering a questionnaire in French language,
- Child among whom the parents(relatives) or the legal representatives accepted the principle of the participation in this study, and having signed a consent,
- Child granting to participate in the study.
Who cannot join
- Child died between the birth and dates her(it) evaluation,
- Child presenting a cerebral palsy
- Child among whom the parents(relatives) or the legal representatives refused that their child participates in this study
Trial locations and contacts
1 site in 1 country.
About this study
AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born very preterm (<28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the QoL reported by a French general population of reference. 3) to determine whether socio-demographic factors, neonatal features and neurocognitive status were impacting their QoL.
METHODS:
Read more
- Multi-centre study: 6 French level three perinatal care units (Marseille, Montpellier, Nantes, Nîmes, Nice and Rouen).
- Inclusion criteria: all infants born before 28 weeks of gestation between January 2005 and December 2007, from 7 to 9 years old of age at the time of evaluation.
- Written agreement to participate: collected from parents.
- Data collection: reports of children's QoL by children and their parents (using standardized validated questionnaires); clinical information about the children, obtained through a medical examination; children neurocognitive profile.
- Duration of inclusion: over 24 months.
- Population: of the six structures, approximately 300 children will be evaluated consistent with the active files of the participating centres and an attrition rate of 30%.
PERSPECTIVES This is one of the first studies to collect self-reported data on quality of life of school-age children (7-9 years) born before 28 weeks of gestation. A better understanding of demographic and clinical determinants of QOL of school-age very preterm children may help clinicians involved in the care of these children in their ethical and medical considerations.
- Conditions
- CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
- Being tested
- questionary on quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionary on quality of lifeOther
| Study group | Role | What they receive |
|---|---|---|
| quality of life | Other | Not described Receives: Other: questionary on quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
data on quality of life of school-age children born prematurely
Measured: 3 years
Secondary outcomes (1)
better understanding of demographic and clinical determinants of QOL of school-age
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CHILDREN BORN VERY PRETERM AT SCHOOL-AGEStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675726
- Sponsor's protocol ID
- 2012-A00193-40
- Other IDs
- 2012-02
- Status last verified
- Aug 2017
- First submitted
- 28 Aug 2012
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gire C, Resseguier N, Brevaut-Malaty V, Marret S, Cambonie G, Souksi-Medioni I, Muller JB, Garcia P, Berbis J, Tosello B, Auquier P; GPQoL study Group. Quality of life of extremely preterm school-age children without major handicap: a cross-sectional observational study. Arch Dis Child. 2019 Apr;104(4):333-339. doi: 10.1136/archdischild-2018-315046. Epub 2018 Jun 30.
PubMed 29960997
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
- ClinicalTrials.gov ID
- NCT01675726
- Acronym / sponsor ID
- 2012-A00193-40
- Conditions
- CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 30 Aug 2012 (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.
AIMS The aims were 1) to describe the quality of life (QoL) of a cohort of children born very preterm (<28 weeks of gestation) aged 7 to 9 years; 2) to compare children's QoL to the QoL reported by a French general population of reference. 3) to determine whether socio-demographic factors, neonatal features and neurocognitive status were impacting their QoL.
METHODS:
- Multi-centre study: 6 French level three perinatal care units (Marseille, Montpellier, Nantes, Nîmes, Nice and Rouen).
- Inclusion criteria: all infants born before 28 weeks of gestation between January 2005 and December 2007, from 7 to 9 years old of age at the time of evaluation.
- Written agreement to participate: collected from parents.
- Data collection: reports of children's QoL by children and their parents (using standardized validated questionnaires); clinical information about the children, obtained through a medical examination; children neurocognitive profile.
- Duration of inclusion: over 24 months.
- Population: of the six structures, approximately 300 children will be evaluated consistent with the active files of the participating centres and an attrition rate of 30%.
PERSPECTIVES This is one of the first studies to collect self-reported data on quality of life of school-age children (7-9 years) born before 28 weeks of gestation. A better understanding of demographic and clinical determinants of QOL of school-age very preterm children may help clinicians involved in the care of these children in their ethical and medical considerations.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| quality of life | Other | Other: questionary on quality of life |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Child been born between 01/01/2005 and the inclusive 31/12/2007,
- Extreme premature born Child before 28 weeks of amenorrhea,
- Child hospitalized after the birth in a level maternity 3 (been born " inborn " or " outborn ")
- Not dead Child,
- Child not presenting a cerebral palsy,
Key exclusion criteria (3 listed)
- Child died between the birth and dates her(it) evaluation,
- Child presenting a cerebral palsy
- Child among whom the parents(relatives) or the legal representatives refused that their child participates in this 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 |
|---|---|---|
| questionary on quality of life | Other | quality of life |
Primary outcome
data on quality of life of school-age children born prematurely
Time frame: 3 years
1 secondary outcome
better understanding of demographic and clinical determinants of QOL of school-age
Time frame: 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 30 Aug 2017.
- Derived from this study: PubMed 29960997Gire C, Resseguier N, Brevaut-Malaty V, Marret S, Cambonie G, Souksi-Medioni I, Muller JB, Garcia P, Berbis J, Tosello B, Auquier P; GPQoL study Group. Quality of life of extremely preterm school-age children without major handicap: a cross-sectional observational study. Arch Dis Child. 2019 Apr;104(4):333-339. doi: 10.1136/archdischild-2018-315046. Epub 2018 Jun 30.
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.
BERNARD BELAIGUES study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionary on quality of life in people with CHILDREN BORN VERY PRETERM AT SCHOOL-AGE, run by Assistance Publique Hopitaux De Marseille 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 8 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 30 Aug 2017. 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?
data on quality of life of school-age children born prematurely (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01675726, which also lists 1 linked publication.
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 30 Aug 2017.