Growth, Health and Development in Children Born Extremely Preterm (PEP11)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01150071
Recruitment Status : Completed
First Posted : June 24, 2010
Last Update Posted : June 3, 2015
Haukeland University Hospital
Information provided by (Responsible Party):
Trond Markestad, 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.

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

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 : Observational
Actual Enrollment : 232 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Growth, Health and Development in Children Born Extremely Preterm
Study Start Date : August 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2014

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

Primary Outcome Measures :
  1. growth [ Time Frame: Eleven years old (years 2010, 2011) ]
    Heigh and weight. In a subpopulation of 80 children: Also skin fold thicknesses and waist circumference

  2. Mental health [ Time Frame: Eleven years old (years 2010, 2011) ]
    Questionnaires completed by parents (Strengths and Difficulties questionnaire, Parenting Stress Index,ASSQ)

  3. Cognitive function [ Time Frame: Eleven years old (years 2010, 2011) ]
    Grades in 5th grade in school

  4. Pulmonary function [ Time Frame: Eleven years of age (years 2010,2011) ]
    Spirometry on a subgroup of 80 and 80 controls

  5. Cerebral function [ Time Frame: Eleven years of age (years 2010,2011) ]
    fMRI on a subgroup of 40 and 40 controls

  6. Bone density [ Time Frame: Eleven years of age (years 2010,2011) ]
    DXA measurements on a subgroup of 80 and 80 controls

Biospecimen Retention:   Samples Without DNA
On a subpopulation blood for inflammatory parameters will be collected

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01150071

Haukeland University Hospital
Bergen, Norway, N-5021
Stavanger University Hospital
Stavanger, Norway, N-4068
Sponsors and Collaborators
University of Bergen
Haukeland University Hospital
Principal Investigator: Trond Markestad, MD, PhD University of Bergen, Faculty of Medicine

Responsible Party: Trond Markestad, Professor, University of Bergen Identifier: NCT01150071     History of Changes
Other Study ID Numbers: 2009/2271-1
First Posted: June 24, 2010    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by Trond Markestad, University of Bergen:
extremely premature infant
mental health
lung function
muscle mass
bone density
magnetic Resonance imaging

Additional relevant MeSH terms:
Lung Diseases
Birth Weight
Cognition Disorders
Lung Diseases, Obstructive
Neurobehavioral Manifestations
Bone Diseases
Pathologic Processes
Respiratory Tract Diseases
Body Weight
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Musculoskeletal Diseases