QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE

Study Overview
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Brief Summary
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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.

Official Title
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QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE

Conditions
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CHILDREN BORN VERY PRETERM AT SCHOOL-AGE

Intervention / Treatment
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* Other: questionary on quality of life


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: quality of life<br> | Other: questionary on quality of life<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| data on quality of life of school-age children born prematurely |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| better understanding of demographic and clinical determinants of QOL of school-age |  | 3 years |