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Completed

NCT Number: NCT02842645

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

"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.

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Key information

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland universitet sykehus, Bergen, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Foetal exposure of drugs during pregnancy.

Exclusion criteria

  • Non exposed children

Treatment and study plan

Primary outcomes

  1. Mental Health Disorder

    Time frame: 2012

    Questionaire regarding mental health: Strength and Difficulties Questionnaires

Other outcomes

  1. Social status

    Time frame: 2012

    Questionaire regarding social status

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jul 25, 2016
Registry last updated
Aug 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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