Livet Skal Leves (A Life to Live)

Heart Defects, Congenital Clinical Trial

Official title:

Heart Defects in Infants- Detection, Rescue and Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03957512
• Other study ID #: REK2010/392
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

Procedure:
• Heart surgery
All invasive procedures

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	All deaths including prenatal termination of pregnancy	0-2 years