Infant, Extremely Low Birth WeightPEP11NCT01150071
Growth, Health and Development in Children Born Extremely Preterm
An observational study of Infant, Extremely Low Birth Weight and Lung Diseases, Obstructive, run by University of Bergen at 2 sites in Norway.
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… Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Infant, Extremely Low Birth Weight, Lung Diseases, Obstructive, Disorder of Bone Density and Structure, Unspecified
- How many people
- 232 participants
- Where
- 2 sitesNorway
- Study dates
- Aug 2010to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- No healthy volunteers
- Child
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)
Who may be able to join
- Born in 1999 and 2000 with gestational age < 28 weeks or birth weight < 1000 g
- still living when 11 years old
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital
Bergen, N-5021
Stavanger University Hospital
Stavanger, N-4068
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Lung Diseases, Obstructive, Cognition Disorders, Neurobehavioral Manifestations, Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
growth
Heigh and weight. In a subpopulation of 80 children: Also skin fold thicknesses and waist circumference
Measured: Eleven years old (years 2010, 2011)
Mental health
Questionnaires completed by parents (Strengths and Difficulties questionnaire, Parenting Stress Index,ASSQ)
Measured: Eleven years old (years 2010, 2011)
Cognitive function
Grades in 5th grade in school
Measured: Eleven years old (years 2010, 2011)
Pulmonary function
Spirometry on a subgroup of 80 and 80 controls
Measured: Eleven years of age (years 2010,2011)
Cerebral function
fMRI on a subgroup of 40 and 40 controls
Measured: Eleven years of age (years 2010,2011)
Bone density
DXA measurements on a subgroup of 80 and 80 controls
Measured: Eleven years of age (years 2010,2011)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Extremely Low Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Principal investigator, Trond Markestad, University of Bergen
- Investigators
- Trond Markestad, MD, PhD, Principal investigator, University of Bergen, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150071
- Sponsor's protocol ID
- 2009/2271-1
- Acronym
- PEP11
- Status last verified
- Jun 2015
- First submitted
- 23 Jun 2010
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth, Health and Development in Children Born Extremely Preterm
- ClinicalTrials.gov ID
- NCT01150071
- Acronym / sponsor ID
- PEP11 / 2009/2271-1
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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)
Key inclusion criteria (2 listed)
- Born in 1999 and 2000 with gestational age < 28 weeks or birth weight < 1000 g
- still living when 11 years old
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Mental health
Time frame: Eleven years old (years 2010, 2011)
Questionnaires completed by parents (Strengths and Difficulties questionnaire, Parenting Stress Index,ASSQ)
Cognitive function
Time frame: Eleven years old (years 2010, 2011)
Grades in 5th grade in school
Pulmonary function
Time frame: Eleven years of age (years 2010,2011)
Spirometry on a subgroup of 80 and 80 controls
Cerebral function
Time frame: Eleven years of age (years 2010,2011)
fMRI on a subgroup of 40 and 40 controls
Bone density
Time frame: Eleven years of age (years 2010,2011)
DXA measurements on a subgroup of 80 and 80 controls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trond Markestad, MD, PhD principal investigator
University of Bergen, Faculty of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Extremely Low Birth Weight and Lung Diseases, Obstructive, run by University of Bergen at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
growth (time frame: Eleven years old (years 2010, 2011)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015; AzTrials last refreshed its copy on 26 Oct 2026.