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

Not Applicable

Completed

• Conditions: CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
• Interventions: Other: questionary on quality of life

• Registration Number: NCT01675726
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-30
• Study Start: 2013-01
• Primary Completion: 2016-01
• Status Verified: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-29
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
quality of life	questionary on quality of life	-

Primary Outcome Measures

Name	Time	Method
data on quality of life of school-age children born prematurely	3 years

Secondary Outcome Measures

Name	Time	Method
better understanding of demographic and clinical determinants of QOL of school-age	3 years

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France