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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-08-31

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.

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Detailed Description

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Conditions

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CHILDREN BORN VERY PRETERM AT SCHOOL-AGE

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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quality of life

Group Type OTHER

questionary on quality of life

Intervention Type OTHER

Interventions

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questionary on quality of life

Intervention Type OTHER

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

Minimum Eligible Age

7 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No