- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03957512
Livet Skal Leves (A Life to Live)
Heart Defects in Infants- Detection, Rescue and Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The project is designed as retrospective cohort study based on nationwide registry data of children born 2004-16. The project group has extensive experience of similar research, and includes representatives from different fields and levels of health care.
The results will provide a solid fundament for improvement of today's clinical practice, including development of knowledge-based routines in neonatal medicine and planning of health care services. Implementation is given particular attention, and will be managed in an interdisciplinary setting. The project will be of major relevance for the patients and their families as well as medical professionals at all levels of health care.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oslo, Norway
- Oslo University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Fetuses with severe CHDs who were identified by antenatal ultrasound screening, and where the pregnancy was terminated
- Children with severe congenital heart defects born in Norway 2004-18
Exclusion Criteria:
- Lack of parental consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 0-2 years
|
All deaths including prenatal termination of pregnancy
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0-2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Henrik Holmstrøm, Dr Med, Oslo University Hospital/University of Oslo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK2010/392
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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