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Growth-Health and Development in Children Exposed to Drugs During Pregnancy

H

Haukeland University Hospital

Status

Completed

Conditions

Growth Failure
Mental Health Disorder
Foetal Exposure During Pregnancy

Study type

Observational

Funder types

Other

Identifiers

NCT02842645
2010/3301

Details and patient eligibility

About

"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.

Enrollment

170 patients

Sex

All

Ages

2 to 15 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Foetal exposure of drugs during pregnancy.

Exclusion criteria

  • Non exposed children

Trial design

170 participants in 2 patient groups

Control
Description:
Children born at term and not exposed to drugs during pregnancy
Case
Description:
Case = Children exposed to drugs during pregnancy

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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