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Umbilical Vessel Catheterization Under ECG Monitoring and Guidance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03898596
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : February 21, 2020
Information provided by (Responsible Party):
Chi-Ho Ban Tsui, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pediatric ALL Diagnostic Test: ECG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Umbilical Vessel Catheterization Under ECG Monitoring and Guidance
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 45 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03898596

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Contact: Ahtziri Fonseca 6504970927

Sponsors and Collaborators
Stanford University
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Responsible Party: Chi-Ho Ban Tsui, Professor-Med Ctr Line, Stanford University Identifier: NCT03898596    
Other Study ID Numbers: 49778
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chi-Ho Ban Tsui, Stanford University:
Umbilical Vein Catheterization