Growth-Health and Development in Children Exposed to Drugs During Pregnancy
NCT ID: NCT02842645
Last Updated: 2016-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
170 participants
OBSERVATIONAL
2011-02-28
2013-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prognosis of Extremely Premature Birth
NCT01150396
Fetal Growth and Pregnancy Complications Among Women With Heart Disease
NCT03657823
Metabolic and Endocrine Status in Women With Prior Preterm Birth
NCT01355536
Hemodynamic Changes During Normal Pregnancy
NCT00682201
Promoting Safe Medication Use in Pregnancy in the Era of Real-World Data - The SafeStart Study
NCT04182750
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Children born at term and not exposed to drugs during pregnancy
No interventions assigned to this group
Case
Case = Children exposed to drugs during pregnancy
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2 Years
15 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Haukeland University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Irene B Elgen, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Child and Adolscent Psychiatry, Haukeland University Hospital, N-5018 Bergen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Haukeland universitet sykehus
Bergen, , Norway
Haukelans universitetssykehus
Bergen, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010/3301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.