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临床试验/NCT03700619
NCT03700619已完成不适用

Assessment of Executive Functions in Preterm Children in 11 to 12 Year Old From the Behavioral Rating Inventory of Executive Function (BRIEF) Questionnaire

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 355 人开始时间: 2019年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
355
试验地点
1
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
11 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •patient in 11 to 12 year old, included in LIFT cohort

排除标准

  • •Congenital abnormalities including nervous system malformations; genetic diseases; incomplete understanding of written and oral French by parents

结局指标

主要结局

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.

时间窗: 11 to 12 years after preterm birth.

The sum of the 86 items is calculated.

次要结局

  • Find neonatal factors associated with executive functions disorders in former prematures in 11 to 12 year old(11 to 12 years after preterm birth)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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