Executive Functions and Preterm Children in 3 to 4 Year Old

Preterm Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700463
• Other study ID #: RC18_0147
• Status: Completed
• Start date: October 16, 2018
• Est. completion date: June 15, 2019

Study information

• Verified date: August 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: June 15, 2019
• Est. primary completion date: June 15, 2019
• Gender: All
• Age group: 3 Years to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant

Intervention

Other:
• BRIEF parental survey
Estimate incidence of executive functions disorders in preterm children in 3 to 4 year old, born less than 34 weeks of gestation

Locations

Country	Name	City	State
France	CHU Nantes	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	sum of 63 items is calculated	3 to 4 years after preterm birth
Secondary	neonatal factors	Neonatal 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.	3 to 4 years after preterm birth