Executive Functions and Preterm Children in 11 to 12 Year Old

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03700619
Collaborator
(none)
355
1
4
88.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: BRIEF parental survey

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 Design

Study Type:
Observational
Actual Enrollment :
355 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Assessment of Executive Functions in Preterm Children in 11 to 12 Year Old From the Behavioral Rating Inventory of Executive Function (BRIEF) Questionnaire
Actual Study Start Date :
Jan 30, 2019
Actual Primary Completion Date :
Jun 1, 2019
Actual Study Completion Date :
Jun 1, 2019

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Nantes Nantes France 44000

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT03700619
Other Study ID Numbers:
  • RC18_0201
First Posted:
Oct 9, 2018
Last Update Posted:
Sep 10, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2021