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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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
Growth Failure Mental Health Disorder Foetal Exposure During Pregnancy

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Study Type : Observational
Actual Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Group/Cohort
Control
Children born at term and not exposed to drugs during pregnancy
Case
Case = Children exposed to drugs during pregnancy



Primary Outcome Measures :
  1. Mental Health Disorder [ Time Frame: 2012 ]
    Questionaire regarding mental health: Strength and Difficulties Questionnaires


Other Outcome Measures:
  1. Social status [ Time Frame: 2012 ]
    Questionaire regarding social status



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • Foetal exposure of drugs during pregnancy.

Exclusion Criteria:

  • Non exposed children

Information from the National Library of Medicine

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


Locations
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Norway
Haukeland universitet sykehus
Bergen, Norway, 5021
Haukelans universitetssykehus
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
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Principal Investigator: Irene B Elgen, Professor Department of Child and Adolscent Psychiatry, Haukeland University Hospital, N-5018 Bergen

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT02842645     History of Changes
Other Study ID Numbers: 2010/3301
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Haukeland University Hospital:
Foetal Exposure During Pregnancy
Health
Growth
Additional relevant MeSH terms:
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Failure to Thrive
Mental Disorders
Signs and Symptoms