Livet Skal Leves (A Life to Live)

NCT ID: NCT03957512

Last Updated: 2019-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Heart Defects, Congenital

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Heart surgery

All invasive procedures

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Henrik Holmstrøm

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henrik Holmstrøm, Dr Med

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital/University of Oslo

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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REK2010/392

Identifier Type: -

Identifier Source: org_study_id

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