Growth, Health and Development in Children Born Extremely Preterm

Growth, Health and Development in Children Born Extremely Preterm

Sponsors

Lead sponsor: University of Bergen

Collaborator: Haukeland University Hospital

Source University of Bergen
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.

Overall Status Completed
Start Date August 2010
Completion Date December 2014
Primary Completion Date December 2012
Study Type Observational
Primary Outcome
Measure Time Frame
growth Eleven years old (years 2010, 2011)
Mental health Eleven years old (years 2010, 2011)
Cognitive function Eleven years old (years 2010, 2011)
Pulmonary function Eleven years of age (years 2010,2011)
Cerebral function Eleven years of age (years 2010,2011)
Bone density Eleven years of age (years 2010,2011)
Enrollment 232
Condition
Eligibility

Sampling method: Non-Probability Sample

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

Gender: All

Minimum age: 10 Years

Maximum age: 12 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Trond Markestad, MD, PhD Principal Investigator University of Bergen, Faculty of Medicine
Location
facility
Haukeland University Hospital | Bergen, N-5021, Norway
Stavanger University Hospital | Stavanger, N-4068, Norway
Location Countries

Norway

Verification Date

June 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Bergen

Investigator full name: Trond Markestad

Investigator title: Professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Children born extremely preterm

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

Acronym PEP11
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov