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Executive Functions and Preterm Children in 3 to 4 Year Old

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03700463
Enrollment
356
Registered
2018-10-09
Start date
2018-10-16
Completion date
2019-06-15
Last updated
2019-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Infant

Brief summary

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.

Detailed description

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.

Interventions

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

Sponsors

University Hospital, Angers
CollaboratorOTHER_GOV
Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 4 Years

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

Design outcomes

Primary

MeasureTime frameDescription
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.3 to 4 years after preterm birthsum of 63 items is calculated

Secondary

MeasureTime frameDescription
neonatal factors3 to 4 years after preterm birthNeonatal 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026