QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
Primary Purpose
CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionary on quality of life
Sponsored by
About this trial
This is an interventional other trial for CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
quality of life
Arm Description
Outcomes
Primary Outcome Measures
data on quality of life of school-age children born prematurely
Secondary Outcome Measures
better understanding of demographic and clinical determinants of QOL of school-age
Full Information
NCT ID
NCT01675726
First Posted
August 28, 2012
Last Updated
August 29, 2017
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01675726
Brief Title
QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
Official Title
QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
quality of life
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
questionary on quality of life
Primary Outcome Measure Information:
Title
data on quality of life of school-age children born prematurely
Time Frame
3 years
Secondary Outcome Measure Information:
Title
better understanding of demographic and clinical determinants of QOL of school-age
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29960997
Citation
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.
Results Reference
derived
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QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
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