Growth FailureNCT02842645
Growth-Health and Development in Children Exposed to Drugs During Pregnancy
An observational study of Growth Failure and Mental Health Disorder, run by Haukeland University Hospital at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Failure, Mental Health Disorder, Foetal Exposure During Pregnancy
- How many people
- 170 participants
- Where
- 2 sitesNorway
- Study dates
- Feb 2011to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Foetal exposure of drugs during pregnancy.
Who cannot join
- Non exposed children
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland universitet sykehus
Bergen, 5021
Haukelans universitetssykehus
Bergen, 5021
About this study
Official title: Growth-Health and Development in Children Exposed to Drugs During Pregnancy.
"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.
Read more
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.
- Keywords
- Foetal Exposure During Pregnancy, Health, Growth
- Medical subject headings
- Failure to Thrive, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Children born at term and not exposed to drugs during pregnancy | |
| Case | Case = Children exposed to drugs during pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health Disorder
Questionaire regarding mental health: Strength and Difficulties Questionnaires
Measured: 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startFeb 2011
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth FailureStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene B Elgen, Professor, Principal investigator, Department of Child and Adolscent Psychiatry, Haukeland University Hospital, N-5018 Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842645
- Sponsor's protocol ID
- 2010/3301
- Status last verified
- Aug 2016
- First submitted
- 1 Apr 2011
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth-Health and Development in Children Exposed to Drugs During Pregnancy.
- ClinicalTrials.gov ID
- NCT02842645
- Acronym / sponsor ID
- 2010/3301
- Keywords
- Foetal Exposure During Pregnancy, Health, Growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Children born at term and not exposed to drugs during pregnancy |
| Case | – | –Case = Children exposed to drugs during pregnancy |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Foetal exposure of drugs during pregnancy.
Key exclusion criteria (1 listed)
- Non exposed children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mental Health Disorder
Time frame: 2012
Questionaire regarding mental health: Strength and Difficulties Questionnaires
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene B Elgen, Professor principal investigator
Department of Child and Adolscent Psychiatry, Haukeland University Hospital, N-5018 Bergen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Failure and Mental Health Disorder, run by Haukeland University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Disorder (time frame: 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.