Growth, Health and Development in Children Born Extremely Preterm

NCT01150071 | Completed

• 1 other identifier: 2009/2271-1
• Study Type: observational
• Target: 232
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

extremely premature infant; follow-up; behavior; growth; mental health; lung function; spirometry; muscle mass; bone density; magnetic Resonance imaging

Outcome Measures

Primary Outcomes (6)

• growth

  Heigh and weight. In a subpopulation of 80 children: Also skin fold thicknesses and waist circumference

  Eleven years old (years 2010, 2011)

• Mental health

  Questionnaires completed by parents (Strengths and Difficulties questionnaire, Parenting Stress Index,ASSQ)

  Eleven years old (years 2010, 2011)

• Cognitive function

  Grades in 5th grade in school

  Eleven years old (years 2010, 2011)

• Pulmonary function

  Spirometry on a subgroup of 80 and 80 controls

  Eleven years of age (years 2010,2011)

• Cerebral function

  fMRI on a subgroup of 40 and 40 controls

  Eleven years of age (years 2010,2011)

• Bone density

  DXA measurements on a subgroup of 80 and 80 controls

  Eleven years of age (years 2010,2011)

Study Arms (1)

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

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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)

You may qualify if:

• Born in 1999 and 2000 with gestational age \< 28 weeks or birth weight \< 1000 g
• still living when 11 years old

You may not qualify if:

• None

Sponsors & Collaborators

• University of Bergen: lead
• Haukeland University Hospital: collaborator

Study Sites (2)

Haukeland University Hospital

Bergen, N-5021, Norway

Location

Stavanger University Hospital

Stavanger, N-4068, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

On a subpopulation blood for inflammatory parameters will be collected

MeSH Terms

Conditions

Lung Diseases, Obstructive; Cognition Disorders; Neurobehavioral Manifestations; Behavior; Psychological Well-Being

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction

Study Officials

• Trond Markestad, MD, PhD

  University of Bergen, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 24, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2014
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

NO (2)