NCT01610622

Brief Summary

Presently there is no apparatus, clinically available, for routine determination of cardiac output (CO) in children. The goal of this research is to develop new technology that will help determine CO in neonates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 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

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

May 30, 2012

Last Update Submit

May 25, 2016

Conditions

Neonatal Intensive Care

Keywords

Cardiac OutputBlood volumesNeonates

Interventions

COstatus cardiac output measurement with isotonic salineDEVICE

Isotonic saline, which is the indicator, is injected to obtain COstatus cardiac output measurements. No other interventions are made for the purpose of the study.

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients from Neonatal Intensive Care Unit

You may qualify if:

  • All neonatal patients cared for in our ICU with umbilical venous and arterial catheters simultaneously in place for their care, will be eligible.

You may not qualify if:

  • Patients would be excluded if the family/guardian denied permission or if the attending physician felt the patient was not stable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Crouse Hospital

Syracuse, New York, 13210, United States

Location

Study Officials

  • Bonnie Marr, MD

    Crouse Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 4, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 27, 2016

Record last verified: 2016-05

Locations

US(1)