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CompletedNCT01675726Updated Aug 30, 2017

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

An interventional study of questionary on quality of life in CHILDREN BORN VERY PRETERM AT SCHOOL-AGE, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 7 Years to 9 Years. Per ClinicalTrials.gov, last updated 2017-08-30.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
350
Allocation
Not applicable
Ages
7 Years to 9 Years
Sex
All
01

Study summary

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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Conditions studied

  • CHILDREN BORN VERY PRETERM AT SCHOOL-AGE

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03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 350 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

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Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
350 participants (actual)

Study arms

  • Other
    quality of life

    Other: questionary on quality of life

Interventions

  • Otherquestionary on quality of life
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What researchers measure

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

07

Study locations

1 site
  • Assistance Publique Hopitaux de Marseille
    Marseille, 13354, France
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References and documents

Publications

  • Gire C, Resseguier N, Brevaut-Malaty V, Marret S, Cambonie G, Souksi-Medioni I, Muller JB, Garcia P, Berbis J, Tosello B, Auquier P; GPQoL study Group. Quality of life of extremely preterm school-age children without major handicap: a cross-sectional observational study. Arch Dis Child. 2019 Apr;104(4):333-339. doi: 10.1136/archdischild-2018-315046. Epub 2018 Jun 30. PubMed 29960997 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01675726
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Aug 30, 2012
Start date
Jan 2013
Primary completion
Jan 2016
Completion
Aug 2017
Last update
Aug 30, 2017

Study contacts

BERNARD BELAIGUES
study director · Assistance Publique Hopitaux De Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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