Growth, Health and Development in Children Born Extremely Preterm

NCT ID: NCT01150071

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 232 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-12-31

Brief Summary

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

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Children born extremely preterm

national cohort of children born before 28 weeks' gestational age or with a birthweight less than 1000 g. 365 eligible survivors

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Trond Markestad

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trond Markestad, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen, Faculty of Medicine

Locations

Haukeland University Hospital

Bergen, , Norway

Stavanger University Hospital

Stavanger, , Norway

Countries

Norway

Other Identifiers

2009/2271-1

Identifier Type: -

Identifier Source: org_study_id