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OpenTrials
Completed

NCT Number: NCT03700463

Executive Functions and Preterm Children in 3 to 4 Year Old

Preterm children have a high risk for neurodevelopmental impairments. The impact on motor functions and neurosensory functions is demonstrated but the incidenceof executive functions is not described for preterm infants.

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Key information

Age range

3 year–4 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nantes

Nantes, 44000, France

About this study

It is an epidemiologic, observational, prospective study. All patients, included in the LIFT cohort, in 3 to 4 year old during the period study, are contacted by mail. Patientswith congenital anomalies or genetic syndromes are excluded. Children with parents who do not speak French are excluded. Antenatal and postnatal criteria known to be associated with disorders of executive functions are collected as, gestational age, sex, multiple pregnancy, intrauterine growth retardation, antenatal or postnatal steroid use, breastfeeding, cerebral injuries and socio-economic status. After a couple of weeks, parents are contacted by a study manager, by phone call, to collect parental consent and answer parental questions. After consent collect, BRIEF questionnaires are sending. If they wish, parents could give the BRIEF teacher questionnaire to the mean teacher. Teachers send by themselves their response. An informatic version is available with a personal link given especially by mail for each child. All data are anonymous. BRIEF questionnaire is composed of 63 items, exploring 2 main domains: behavior and metacognition. Twenty minutes are necessary to complete questionnaire. In case of no questionnaire return after one month, parents are contacted by phone. The investigators hypothesize a lost to follow-up at 0.25 and no response at 0.35. The response expected is 300 questionnaires.

Who can participate

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

Inclusion criteria

  • patient in 3 to 4 year old, included in LIFT cohort

Exclusion criteria

  • Congenital abnormalities including nervous system malformations; genetic diseases; incomplete understanding of written and oral French by parents

Treatment and study plan

BRIEF parental survey

Other

Estimate incidence of executive functions disorders in preterm children in 3 to 4 year old, born less than 34 weeks of gestation

Primary outcomes

  1. Incidence of disorders of executive functions in 3 to 4 year old which former preterm of gestational age less than 34 weeks, from the Behavioral Rating Inventory of Executive Function questionnaire.

    Time frame: 3 to 4 years after preterm birth

    sum of 63 items is calculated

Secondary outcomes

  1. neonatal factors

    Time frame: 3 to 4 years after preterm birth

    Neonatal factors associated with executive functions disorders in former prematures in 3 to 4 year old and adequacy between BRIEF questionnaire performed/completed by parents and BRIEF questionnaire performed by teacher.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • University Hospital, Angers

Registry information

Official study title

Assessment of Executive Functions in Preterm Children in 3 to 4 Year Old From Behavioral Rating Inventory of Executive Function (BRIEF) Questionnaire

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
Aug 26, 2019

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.

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