Growth-Health and Development in Children Exposed to Drugs During Pregnancy
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|ClinicalTrials.gov Identifier: NCT02842645|
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : August 17, 2016
"Children exposed to alcohol or drugs during pregnancy: Growth, health and development" Background Children exposed to drugs during pregnancy are at risk of developmental disorders. The scope and size of this problem is poorly known in Norway.
Alcohol has a known teratogenic effect on the fetus. How other drugs affect the fetus, is associated with more uncertainty. Withdrawal in the neonatal period has been perceived as the main problem. There is less knowledge about long-term outcome of exposure to drugs during pregnancy.
Aim The aim of the study is to investigate the physical and mental health of children exposed to drugs during pregnancy. Identify the children's need for measures in the home and school, and how many of the children who are taken care of in fostercare.
A sample of the children will be offered radiological examination of the brain (f-MRI). The purpose is to study the relationship between exposure to drugs, child development, environment and organic brain dysfunction.
Design The project is a quantitative study. The relationship between exposure to drugs and development will be measured by questionnaires, clinical examination, neuropsychological tests and radiological examination (f-MRI).
Children aged 2-15years who were referred, examined or treated for drug related problems at the Department of Pediatrics, Haukeland University Hospital will be invited to participate in the study.
Information retrieval and examination of the children are expected to be completed during 2011. Data analysis and further processing of data are expected to be completed during 2013.
|Condition or disease|
|Growth Failure Mental Health Disorder Foetal Exposure During Pregnancy|
|Study Type :||Observational|
|Actual Enrollment :||170 participants|
|Official Title:||Growth-Health and Development in Children Exposed to Drugs During Pregnancy.|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||May 2013|
Children born at term and not exposed to drugs during pregnancy
Case = Children exposed to drugs during pregnancy
- Mental Health Disorder [ Time Frame: 2012 ]Questionaire regarding mental health: Strength and Difficulties Questionnaires
- Social status [ Time Frame: 2012 ]Questionaire regarding social status
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842645
|Haukeland universitet sykehus|
|Bergen, Norway, 5021|
|Bergen, Norway, 5021|
|Principal Investigator:||Irene B Elgen, Professor||Department of Child and Adolscent Psychiatry, Haukeland University Hospital, N-5018 Bergen|