Loading search results
PEP11
Sponsor study identifier
observational
232
1 country
2
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 23, 2010
Actual (reported)June 24, 2010
Actual (reported)August 2010
Date type not reportedThis date has not been verified as actual or estimated.
December 2012
Actual (reported)December 2014
Actual (reported)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)
national cohort of children born before 28 weeks' gestational age or with a birthweight less than 1000 g. 365 eligible survivors
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)
Haukeland University Hospital
Bergen, N-5021, Norway
Stavanger University Hospital
Stavanger, N-4068, Norway
On a subpopulation blood for inflammatory parameters will be collected
Trond Markestad, MD, PhD
University of Bergen, Faculty of Medicine
232 participants (actual enrollment reported by the registry).
First Submitted
June 23, 2010
First Posted
June 24, 2010
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
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)
Contact the study team to confirm eligibility.
Primary Completion
December 2012
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
June 3, 2015
Record last verified: 2015-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: