CHILDREN BORN VERY PRETERM AT SCHOOL-AGE Clinical Trial
Official title:
QUALITY OF LIFE OF CHILDREN BORN VERY PRETERM AT SCHOOL-AGE
| Verified date | August 2017 |
| Source | Assistance Publique Hopitaux De Marseille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 350 |
| Est. completion date | August 2017 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 7 Years to 9 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | data on quality of life of school-age children born prematurely | 3 years | ||
| Secondary | better understanding of demographic and clinical determinants of QOL of school-age | 3 years |