NCT03411512

Brief Summary

Congenital Heart Defects and NIRS

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2012

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

December 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2014

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

January 19, 2018

Last Update Submit

January 26, 2018

Conditions

Heart Defects, Congenital

Keywords

congenital heart defectsnear-infrared spectroscopynewborntissue oxygenation

Outcome Measures

Primary Outcomes (1)

  • rSO2

    regional tissue oxygenation assessed by NIRS

    RSO2 values were obtained after 30 minute calm down period to enable stable recordings on each channel by averaging five minutes recorded values.

Study Arms (2)

CHD

Newborns with structural congenital heart defects. The exclusion criteria were pulmonary or neurological disease, perinatal asphyxia, acute illness, prematurity and congenital abnormality other than CHD.

Healthy controls

The control group comprised of healthy matched newborns without a diagnosed CHD.

Eligibility Criteria

Age1 Day - 4 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

term newborns

You may qualify if:

  • Investigators included term newborns with critical structural CHD (of different types) who required surgical or transcatheter procedure in the first year of life. CHD were diagnosed by pediatric cardiologist by clinical examination and echocardiography.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, Petja Fister, MD, PhD

Study Record Dates

First Submitted

January 19, 2018

First Posted

January 26, 2018

Study Start

December 1, 2012

Primary Completion

April 30, 2014

Study Completion

May 31, 2014

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

SL(1)