Clinical trial NCT01150071: Growth, Health and Development in Children Born Extremely Preterm
Official title: Growth, Health and Development in Children Born Extremely Preterm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Extremely Low Birth Weight
Lung Diseases, Obstructive
Disorder of Bone Density and Structure, Unspecified
Cognition Disorders
Neurobehavioral Manifestations
Keywords: extremely premature infant
follow-up
behavior
growth
mental health
lung function
spirometry
muscle mass
bone density
magnetic Resonance imaging
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2010-06-24
Enrollment: 232
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All extremely preterm infants (gestational age \< 28 weeks or birth weight \< 1000 g born in Norway in 1999 and 2000 and still living at age 11 years. Postal survey on outcome. In addition a subgroup (80 out of 365)living in Western Norway will be examined with respect to general health, lung function, mental development, quality of life and cerebral imaging (fMRI)

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.

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

Primary outcomes:
measure: growth
timeFrame: Eleven years old (years 2010, 2011)
measure: Mental health
timeFrame: Eleven years old (years 2010, 2011)
measure: Cognitive function
timeFrame: Eleven years old (years 2010, 2011)
measure: Pulmonary function
timeFrame: Eleven years of age (years 2010,2011)
measure: Cerebral function
timeFrame: Eleven years of age (years 2010,2011)
measure: Bone density
timeFrame: Eleven years of age (years 2010,2011)
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: University of Bergen, Faculty of Medicine
name: Trond Markestad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: