Executive Functions and Preterm Children in 11 to 12 Year Old

Completed

• Conditions: Preterm Infant

• Registration Number: NCT03700619
• Lead Sponsor: Nantes University Hospital

Brief Summary

Preterm children have a high risk for neurodevelopmental impairments. The impact on motor functions and neurosensory functions is demonstrated but the incidence of 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 11 to 12 year old during the period study, are contacted by mail. Patients with 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 some 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 86 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.

Study Timeline

• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-09
• Study Start: 2019-01-30
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

• patient in 11 to 12 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of disorders of executive functions in 11 to 12 year old in former preterm of gestational age less than 34 weeks, from the Behavioral Rating Inventory of Executive Function questionnaire.	11 to 12 years after preterm birth.	The sum of the 86 items is calculated.

Secondary Outcome Measures

Name	Time	Method
Find neonatal factors associated with executive functions disorders in former prematures in 11 to 12 year old	11 to 12 years after preterm birth	estimate adequacy between BRIEF questionnaire performed/completed by parents and BRIEF questionnaire performed by teacher.

Trial Locations

Locations (1)

CHU Nantes; 🇫🇷 Nantes, France