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

August 29, 2017 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: quality of life
Other: questionary on quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
data on quality of life of school-age children born prematurely
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
better understanding of demographic and clinical determinants of QOL of school-age
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 30, 2012

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A00193-40
  • 2012-02 (AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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