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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01675726
Enrollment
350
Registered
2012-08-30
Start date
2013-01-31
Completion date
2017-08-31
Last updated
2017-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHILDREN BORN VERY PRETERM AT SCHOOL-AGE

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.

Interventions

OTHERquestionary on quality of life

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 9 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
data on quality of life of school-age children born prematurely3 years

Secondary

MeasureTime frame
better understanding of demographic and clinical determinants of QOL of school-age3 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026