Growth, Health and Development in Children Born Extremely Preterm

Lung Diseases, Obstructive Clinical Trial

— PEP11  

Official title:

Growth, Health and Development in Children Born Extremely Preterm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150071
• Other study ID #: 2009/2271-1
• Status: Completed
• Phase: N/A
• First received: June 23, 2010
• Last updated: June 1, 2015
• Start date: August 2010
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: December 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 12 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Stavanger University Hospital	Stavanger

Sponsors (2)

Lead Sponsor	Collaborator
University of Bergen	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	growth	Heigh and weight. In a subpopulation of 80 children: Also skin fold thicknesses and waist circumference	Eleven years old (years 2010, 2011)	No
Primary	Mental health	Questionnaires completed by parents (Strengths and Difficulties questionnaire, Parenting Stress Index,ASSQ)	Eleven years old (years 2010, 2011)	No
Primary	Cognitive function	Grades in 5th grade in school	Eleven years old (years 2010, 2011)	No
Primary	Pulmonary function	Spirometry on a subgroup of 80 and 80 controls	Eleven years of age (years 2010,2011)	No
Primary	Cerebral function	fMRI on a subgroup of 40 and 40 controls	Eleven years of age (years 2010,2011)	No
Primary	Bone density	DXA measurements on a subgroup of 80 and 80 controls	Eleven years of age (years 2010,2011)	No