NCT03957512

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
Last Updated

May 22, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

May 18, 2019

Last Update Submit

May 21, 2019

Conditions

Heart Defects, Congenital

Outcome Measures

Primary Outcomes (1)

  • Mortality

    All deaths including prenatal termination of pregnancy

    0-2 years

Interventions

Heart surgeryPROCEDURE

All invasive procedures

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

National population

You may qualify if:

  • 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

You may not qualify if:

  • Lack of parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Henrik Holmstrøm, Dr Med

    Oslo University Hospital/University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 18, 2019

First Posted

May 21, 2019

Study Start

October 1, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2018

Last Updated

May 22, 2019

Record last verified: 2019-05

Locations

NO(1)