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

This study has been completed.
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Trond Markestad, University of Bergen
ClinicalTrials.gov Identifier:
NCT01150071
First received: June 23, 2010
Last updated: June 1, 2015
Last verified: June 2015
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Growth, Health and Development in Children Born Extremely Preterm

Resource links provided by NLM:


Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • growth [ Time Frame: Eleven years old (years 2010, 2011) ] [ Designated as safety issue: No ]
    Heigh and weight. In a subpopulation of 80 children: Also skin fold thicknesses and waist circumference

  • Mental health [ Time Frame: Eleven years old (years 2010, 2011) ] [ Designated as safety issue: No ]
    Questionnaires completed by parents (Strengths and Difficulties questionnaire, Parenting Stress Index,ASSQ)

  • Cognitive function [ Time Frame: Eleven years old (years 2010, 2011) ] [ Designated as safety issue: No ]
    Grades in 5th grade in school

  • Pulmonary function [ Time Frame: Eleven years of age (years 2010,2011) ] [ Designated as safety issue: No ]
    Spirometry on a subgroup of 80 and 80 controls

  • Cerebral function [ Time Frame: Eleven years of age (years 2010,2011) ] [ Designated as safety issue: No ]
    fMRI on a subgroup of 40 and 40 controls

  • Bone density [ Time Frame: Eleven years of age (years 2010,2011) ] [ Designated as safety issue: No ]
    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


Enrollment: 232
Study Start Date: August 2010
Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   10 Years to 12 Years
Genders Eligible for Study:   Both
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150071

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

No publications provided

Responsible Party: Trond Markestad, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT01150071     History of Changes
Other Study ID Numbers: 2009/2271-1
Study First Received: June 23, 2010
Last Updated: June 1, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Bergen:
extremely premature infant
follow-up
behavior
growth
mental health
lung function
spirometry
muscle mass
bone density
magnetic Resonance imaging

Additional relevant MeSH terms:
Birth Weight
Bone Diseases
Cognition Disorders
Lung Diseases
Lung Diseases, Obstructive
Neurobehavioral Manifestations
Body Weight
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Respiratory Tract Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 30, 2015