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

Completed

• Conditions: Growth Failure; Mental Health Disorder; Foetal Exposure During Pregnancy

• Registration Number: NCT02842645
• Lead Sponsor: Haukeland University Hospital

Brief Summary

"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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-04-01
• Primary Completion: 2012-12
• Study Completion: 2013-05
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-25
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• Foetal exposure of drugs during pregnancy.

Exclusion Criteria

• Non exposed children

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mental Health Disorder	2012	Questionaire regarding mental health: Strength and Difficulties Questionnaires

Trial Locations

Locations (2)

Haukelans universitetssykehus; 🇳🇴 Bergen, Norway

Haukeland universitet sykehus; 🇳🇴 Bergen, Norway