Executive Functions and Preterm Children in 3 to 4 Year Old

• ClinicalTrials.gov Identifier: NCT03700463
• Recruitment Status: Completed
• First Posted: October 9, 2018
• Last Update Posted: August 26, 2019
• Sponsor: Nantes University Hospital
• Collaborator: University Hospital, Angers
• Information provided by (Responsible Party): Nantes University Hospital

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 incidenceof executive functions is not described for preterm infants.

Condition or disease	Intervention/treatment
Preterm Infant	Other: BRIEF parental survey

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 356 participants
• Observational Model: Other
• Time Perspective: Prospective
• Target Follow-Up Duration: 1 Year
• Official Title: Assessment of Executive Functions in Preterm Children in 3 to 4 Year Old From Behavioral Rating Inventory of Executive Function (BRIEF) Questionnaire
• Actual Study Start Date: October 16, 2018
• Actual Primary Completion Date: June 15, 2019
• Actual Study Completion Date: June 15, 2019

Groups and Cohorts

Intervention Details:

• 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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. neonatal factors [ Time Frame: 3 to 4 years after preterm birth ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 4 Years (Child)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

patients which former preterm of gestational age less than 34 weeks

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

Contacts and Locations

Locations

France

CHU Nantes

Nantes, France, 44000

Sponsors and Collaborators

Nantes University Hospital

University Hospital, Angers

More Information

Additional Information:

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT03700463
• Other Study ID Numbers: RC18_0147
• First Posted: October 9, 2018
• Last Update Posted: August 26, 2019
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications