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

June 1, 2015 updated by: Trond Markestad, University of Bergen
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.

Study Overview

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

Enrollment (Actual)

232

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bergen, Norway, N-5021
        • Haukeland University Hospital
      • Stavanger, Norway, N-4068
        • Stavanger University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Eleven years old (years 2010, 2011)
Mental health
Time Frame: Eleven years old (years 2010, 2011)
Questionnaires completed by parents (Strengths and Difficulties questionnaire, Parenting Stress Index,ASSQ)
Eleven years old (years 2010, 2011)
Cognitive function
Time Frame: Eleven years old (years 2010, 2011)
Grades in 5th grade in school
Eleven years old (years 2010, 2011)
Pulmonary function
Time Frame: Eleven years of age (years 2010,2011)
Spirometry on a subgroup of 80 and 80 controls
Eleven years of age (years 2010,2011)
Cerebral function
Time Frame: Eleven years of age (years 2010,2011)
fMRI on a subgroup of 40 and 40 controls
Eleven years of age (years 2010,2011)
Bone density
Time Frame: Eleven years of age (years 2010,2011)
DXA measurements on a subgroup of 80 and 80 controls
Eleven years of age (years 2010,2011)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Trond Markestad, MD, PhD, University of Bergen, Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 23, 2010

First Submitted That Met QC Criteria

June 23, 2010

First Posted (Estimate)

June 24, 2010

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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