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

NCT02842645 | Completed DMC

• 1 other identifier: 2010/3301
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 2

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.

Conditions

Growth Failure; Mental Health Disorder; Foetal Exposure During Pregnancy

Keywords

Foetal Exposure During Pregnancy; Health; Growth

Outcome Measures

Primary Outcomes (1)

• Mental Health Disorder

  Questionaire regarding mental health: Strength and Difficulties Questionnaires

  2012

Other Outcomes (1)

• Social status

  2012

Study Arms (2)

Control

Children born at term and not exposed to drugs during pregnancy

Case

Case = Children exposed to drugs during pregnancy

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children exposed to drugs during pregnancy are followed up at school age regarding mental disorders and status of their care situation. Approximately 130 children are invited to the study.

You may qualify if:

• Foetal exposure of drugs during pregnancy.

You may not qualify if:

• Non exposed children

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (2)

Haukeland universitet sykehus

Bergen, 5021, Norway

Location

Haukelans universitetssykehus

Bergen, 5021, Norway

Location

MeSH Terms

Conditions

Failure to Thrive; Mental Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Irene B Elgen, Professor

  Department of Child and Adolscent Psychiatry, Haukeland University Hospital, N-5018 Bergen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: July 25, 2016
• Study Start: February 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: August 17, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)