Umbilical Vessel Catheterization Under ECG Monitoring and Guidance

April 30, 2025 updated by: Chi-Ho Ban Tsui, Stanford University
Umbilical venous catheters (UVC) are typically places with poor guidance and some radiological confirmation. Misplacement of the catheter could lead to its placement in other unintended anatomical areas such as the liver or the spleen, which could be detrimental in critically-ill infants. Our study aims at using a more non-invasive means of placing and continuously monitoring catheter placement using superficial electrocardiogram (ECG) tracings.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Lucille Packard Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Neonate pediatric patient
  • 2 - 6kg
  • Require or currently have UVC

Exclusion Criteria:

  • Participants who do not consent or have parental consent
  • Patients who are clinically unstable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ECG Monitoring
ECG readings will be collected for neonatal patients who require or currently have UVC
Diagnostic test: ECG
An ECG collects superficial readings of heart activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrocardiogram Readings
Time Frame: Duration of ECG placement and reading (typically 15 minutes)
A normal heart rhythm contains a P wave, a QRS, and a T wave. Readings will include amplitude, deflection, and duration of such elements to record electrical heart activity.
Duration of ECG placement and reading (typically 15 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2020

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 49778

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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