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临床试验/NCT01150071
NCT01150071已完成不适用

Growth, Health and Development in Children Born Extremely Preterm

University of Bergen2 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
232
试验地点
2
主要终点
growth

研究概览

简要总结

Background: In a national Norwegian cohort of children born before 28 weeks gestation or with a birth weight less than 1000 g born in 1999 and 2000, 372 survived. Compared with earlier studies survival increased for the most immature infants, but at the cost of more early complications and a high rate of impairments, while the less immature children had fewer early complications and less impairments detectable within 5 years. These changes show the importance of monitoring outcome as treatment modalities change. Large brain haemorrhages were highly predictive of severe disabilities, but we have not found good predictive factors for milder impairments such as cognitive, behavioural and motor difficulties. However, at 5 years later function may be difficult to predict, and the children's potentials are better understood after completing several years in school. Objectives: The children will be re-examined at age 11 in order to assess their physical and mental health, and cognitive, motor and social function, and to determine if early life events and development at 2 and 5 years are predictive of long term health and functioning. MRI-studies, including functional MRI will be performed to examine if different outcomes related to brain function can be explained by differences in brain development. Methods: For all, data will be collected from the compulsory national test in 5th grade and questionnaires to the child, parents and teacher. For children in Western Norway (n=87) extensive examinations of lung and brain function, including clinical diagnostic tests and MRI, will be added. For all aspects of the study the investigators have appropriate current and historic reference populations for comparison. Implications: Knowledge on causes and of early predictions of outcome is needed to give appropriate advice to families, professionals and society, and to develop preventive programs.

详细描述

Questionnaires to parents: On general and neurosensory developmental Health (spesific questionnaire for the study) and pulmonary health (ISAAC-questionnaire). Mental Health and social functioning: Strengths and Difficulties (SDQ) questionnaire (also completed by Teachers), ASSQ and BRIEF.

Addtions for children born in the Western Norway Regional Health Authority:

All the children (n=52) and matched Controls born at term have measurements of height, weight and blood pressures, pulminary function tests, MRI and functional MRI of the brain, Assessment of bone mineralization and distribution of fat and muscle (DXA). Blood is collected in a biobank for assessment of inflammatory variables.

研究设计

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

入排标准

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

入选标准

  • Born in 1999 and 2000 with gestational age < 28 weeks or birth weight < 1000 g
  • still living when 11 years old

排除标准

  • 未提供

结局指标

主要结局

growth

时间窗: Eleven years old (years 2010, 2011)

Heigh and weight. In a subpopulation of 80 children: Also skin fold thicknesses and waist circumference

Cognitive function

时间窗: Eleven years old (years 2010, 2011)

Grades in 5th grade in school

Pulmonary function

时间窗: Eleven years of age (years 2010,2011)

Spirometry on a subgroup of 80 and 80 controls

Cerebral function

时间窗: Eleven years of age (years 2010,2011)

fMRI on a subgroup of 40 and 40 controls

Mental health

时间窗: Eleven years old (years 2010, 2011)

Questionnaires completed by parents (Strengths and Difficulties questionnaire, Parenting Stress Index,ASSQ)

Bone density

时间窗: Eleven years of age (years 2010,2011)

DXA measurements on a subgroup of 80 and 80 controls

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Trond Markestad

Professor

University of Bergen

研究点 (2)

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