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Completed

NCT Number: NCT01150071

Growth, Health and Development in Children Born Extremely Preterm

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.

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Key information

Conditions

Infant, Extremely Low Birth Weight Behavior Cognition Disorders Disorder of Bone Density and Structure, Unspecified Lung Diseases Lung Diseases, Obstructive Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Respiratory Tract Diseases Signs and Symptoms

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Haukeland University Hospital

Registry information

Acronym: PEP11

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Jun 24, 2010
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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