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

Sponsor
Haukeland University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02842645
Collaborator
(none)
170
2
26.9
85
3.2

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Feb 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    May 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Control

    Children born at term and not exposed to drugs during pregnancy

    Case

    Case = Children exposed to drugs during pregnancy

    Outcome Measures

    Primary Outcome Measures

    1. Mental Health Disorder [2012]

      Questionaire regarding mental health: Strength and Difficulties Questionnaires

    Other Outcome Measures

    1. Social status [2012]

      Questionaire regarding social status

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Foetal exposure of drugs during pregnancy.
    Exclusion Criteria:
    • Non exposed children

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Haukeland universitet sykehus Bergen Norway 5021
    2 Haukelans universitetssykehus Bergen Norway 5021

    Sponsors and Collaborators

    • Haukeland University Hospital

    Investigators

    • Principal Investigator: Irene B Elgen, Professor, Department of Child and Adolscent Psychiatry, Haukeland University Hospital, N-5018 Bergen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Haukeland University Hospital
    ClinicalTrials.gov Identifier:
    NCT02842645
    Other Study ID Numbers:
    • 2010/3301
    First Posted:
    Jul 25, 2016
    Last Update Posted:
    Aug 17, 2016
    Last Verified:
    Aug 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Haukeland University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 17, 2016