Skip to main content
OpenTrials
Completed

NCT Number: NCT01675726

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionary on quality of life

Other

Primary outcomes

  1. data on quality of life of school-age children born prematurely

    Time frame: 3 years

Secondary outcomes

  1. better understanding of demographic and clinical determinants of QOL of school-age

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Aug 30, 2012
Registry last updated
Aug 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.