Executive Functions and Preterm Children in 11 to 12 Year Old

Preterm Infant Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700619
• Other study ID #: RC18_0201
• Status: Completed
• Start date: January 30, 2019
• Est. completion date: June 1, 2019

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant

Intervention

Other:
• BRIEF parental survey
estimate incidence of executive functions disorders in preterm children in 11 to 12 year old, born less than 34 weeks of gestation, with the BRIEF parental questionnaire. Effects are potentially important because this study could objectify an increase of risk of executive functions disorders f in preterm children in 11 to 12 year old, and identify associated risk factors. This work could eventually alert pediatrician to be careful at the executive functions and to propose adapted supportive cares.

Locations

Country	Name	City	State
France	CHU Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The sum of the 86 items is calculated.	11 to 12 years after preterm birth.
Secondary	Find neonatal factors associated with executive functions disorders in former prematures in 11 to 12 year old	estimate adequacy between BRIEF questionnaire performed/completed by parents and BRIEF questionnaire performed by teacher.	11 to 12 years after preterm birth