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Clinical Trials/NCT03957512
NCT03957512
Completed
Not Applicable

Heart Defects in Infants- Detection, Rescue and Care

Oslo University Hospital1 site in 1 country3,000 target enrollmentOctober 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Defects, Congenital
Sponsor
Oslo University Hospital
Enrollment
3000
Locations
1
Primary Endpoint
Mortality
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The overall objective of this project is to optimize the use of diagnostic methods and follow-up programs in infants with congenital heart defects (CHDs) in order to reduce death and complications

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
December 31, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Henrik Holmstrøm

Professor

Oslo University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Mortality

Time Frame: 0-2 years

All deaths including prenatal termination of pregnancy

Study Sites (1)

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