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

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

CHILDREN BORN VERY PRETERM AT SCHOOL-AGE

Treatments

Other: questionary on quality of life

Study type

Interventional

Funder types

Other

Identifiers

NCT01675726

2012-A00193-40

2012-02

Details and patient eligibility

About

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.

Enrollment

350 patients

Sex

All

Ages

7 to 9 years old

Volunteers

No Healthy Volunteers

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