- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01150071
Growth, Health and Development in Children Born Extremely Preterm (PEP11)
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bergen, Norway, N-5021
- Haukeland University Hospital
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Stavanger, Norway, N-4068
- Stavanger University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
growth
Time Frame: Eleven years old (years 2010, 2011)
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Heigh and weight.
In a subpopulation of 80 children: Also skin fold thicknesses and waist circumference
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Eleven years old (years 2010, 2011)
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Mental health
Time Frame: Eleven years old (years 2010, 2011)
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Questionnaires completed by parents (Strengths and Difficulties questionnaire, Parenting Stress Index,ASSQ)
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Eleven years old (years 2010, 2011)
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Cognitive function
Time Frame: Eleven years old (years 2010, 2011)
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Grades in 5th grade in school
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Eleven years old (years 2010, 2011)
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Pulmonary function
Time Frame: Eleven years of age (years 2010,2011)
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Spirometry on a subgroup of 80 and 80 controls
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Eleven years of age (years 2010,2011)
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Cerebral function
Time Frame: Eleven years of age (years 2010,2011)
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fMRI on a subgroup of 40 and 40 controls
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Eleven years of age (years 2010,2011)
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Bone density
Time Frame: Eleven years of age (years 2010,2011)
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DXA measurements on a subgroup of 80 and 80 controls
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Eleven years of age (years 2010,2011)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Trond Markestad, MD, PhD, University of Bergen, Faculty of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Respiratory Tract Diseases
- Neurologic Manifestations
- Neurocognitive Disorders
- Body Weight
- Musculoskeletal Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Disease
- Birth Weight
- Bone Diseases
- Neurobehavioral Manifestations
- Cognition Disorders
Other Study ID Numbers
- 2009/2271-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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