Livet Skal Leves (A Life to Live) | NCT03957512

Studies
Livet Skal Leves (A Life to Live)

NCT03957512

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

May 22, 2019Actual

Enrollment

3,000Actual

Phase

Not provided

Conditions

Heart Defects, Congenital

Interventions

Heart surgery

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

May 18, 2019

First Submission Date that Met QC Criteria

May 20, 2019

First Posted Date

May 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2019

Last Update Posted Date

May 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Actual

Name	Type	Description	Arm Group Labels	Other Names
Heart surgery	Procedure	All invasive procedures

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	All deaths including prenatal termination of pregnancy	0-2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Years

Standard Ages

Child

Study Population

National population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henrik Holmstrøm, Dr Med	Oslo University Hospital/University of Oslo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo			Norway

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006348	Cardiac Surgical Procedures

Ancestor Terms

ID	Term
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided