Skip to main content
Clinical Trials/NCT03700463
NCT03700463
Completed
N/A

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

Nantes University Hospital1 site in 1 country356 target enrollmentOctober 16, 2018
ConditionsPreterm Infant

Overview

Phase
N/A
Intervention
Not specified
Conditions
Preterm Infant
Sponsor
Nantes University Hospital
Enrollment
356
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 16, 2018
End Date
June 15, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • neonatal factors(3 to 4 years after preterm birth)

Study Sites (1)

Loading locations...

Similar Trials