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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03898596
Other study ID # 49778
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 25, 2020
Est. completion date June 2024

Study information

Verified date July 2023
Source Stanford University
Contact Chynna Villanueva, BS, RN
Phone 6504986346
Email chynnav@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 1 Day to 45 Days
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ECG
An ECG collects superficial readings of heart activity

Locations

Country Name City State
United States Lucille Packard Children's Hospital Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Electrocardiogram Readings 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)
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