Trials / Completed
CompletedNCT03700463
Executive Functions and Preterm Children in 3 to 4 Year Old
Assessment of Executive Functions in Preterm Children in 3 to 4 Year Old From Behavioral Rating Inventory of Executive Function (BRIEF) Questionnaire
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 356 (actual)
- Sponsor
- Nantes University Hospital · Academic / Other
- Sex
- All
- Age
- 3 Years – 4 Years
- Healthy volunteers
- —
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-10-16
- Primary completion
- 2019-06-15
- Completion
- 2019-06-15
- First posted
- 2018-10-09
- Last updated
- 2019-08-26
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03700463. Inclusion in this directory is not an endorsement.