NCT02655107

Brief Summary

Non-invasive measurement of hemoglobin in infants and neonates scheduled for elective congenital heart surgery, weighing between 3kg and 20 kg. SpHb measurement will be compared to the gold standard of hemoglobin measurement - CO-oximetrie - and to the point-of-care (GEM 3500 premiere).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

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

February 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

1.4 years

First QC Date

December 5, 2015

Last Update Submit

December 18, 2016

Conditions

Hemoglobins

Keywords

blood gas monitoringnon-invasivehemoglobin

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin measurement non-invasively compared to gold standard hemoglobin

    intraoperative

Eligibility Criteria

Age1 Month - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants and neonates undergoing congenital heart surgery weighing between 3kg and 20kg

You may qualify if:

  • scheduled for elective congenital heart surgery
  • routine use of an arterial line
  • weight \>= 3000g

You may not qualify if:

  • urgent surgery
  • premature birth
  • parents refuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Schleswig-Holstein

Kiel, Schleswig-Holstein, 24105, Germany

Location

Study Officials

  • Jochen Renner, PD Dr.

    University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 5, 2015

First Posted

January 13, 2016

Study Start

February 1, 2015

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

December 20, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)