Growth, Health and Development in Children Born Extremely Preterm

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Growth, Health and Development in Children Born Extremely Preterm

Conditions
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Infant, Extremely Low Birth Weight, Lung Diseases, Obstructive, Disorder of Bone Density and Structure, Unspecified, Cognition Disorders, Neurobehavioral Manifestations

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Born in 1999 and 2000 with gestational age < 28 weeks or birth weight < 1000 g still living when 11 years old Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children born extremely preterm<br>national cohort of children born before 28 weeks' gestational age or with a birthweight less than 1000 g. 365 eligible survivors | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| growth | Heigh and weight. In a subpopulation of 80 children: Also skin fold thicknesses and waist circumference | Eleven years old (years 2010, 2011) | 
| Mental health | Questionnaires completed by parents (Strengths and Difficulties questionnaire, Parenting Stress Index,ASSQ) | Eleven years old (years 2010, 2011) | 
| Cognitive function | Grades in 5th grade in school | Eleven years old (years 2010, 2011) | 
| Pulmonary function | Spirometry on a subgroup of 80 and 80 controls | Eleven years of age (years 2010,2011) | 
| Cerebral function | fMRI on a subgroup of 40 and 40 controls | Eleven years of age (years 2010,2011) | 
| Bone density | DXA measurements on a subgroup of 80 and 80 controls | Eleven years of age (years 2010,2011) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extremely premature infant, follow-up, behavior, growth, mental health, lung function, spirometry, muscle mass, bone density, magnetic Resonance imaging