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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.
 
ClinicalTrials.gov Identifier: NCT03898596
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : July 8, 2021
Sponsor:
Information provided by (Responsible Party):
Chi-Ho Ban Tsui, Stanford University

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Umbilical Vessel Catheterization Under ECG Monitoring and Guidance
Actual Study Start Date : August 25, 2020
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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.


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

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03898596


Contacts
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Contact: Chynna Villanueva, BS, RN 6504986346 chynnav@stanford.edu

Locations
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United States, California
Lucille Packard Children's Hospital Recruiting
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Chi-Ho Ban Tsui, Professor-Med Ctr Line, Stanford University
ClinicalTrials.gov Identifier: NCT03898596    
Other Study ID Numbers: 49778
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2021
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: Yes
Keywords provided by Chi-Ho Ban Tsui, Stanford University:
Neonates
Electrocardiogram
Umbilical Vein Catheterization