NCT03898596

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

March 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

August 25, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

5.3 years

First QC Date

March 29, 2019

Last Update Submit

April 30, 2025

Conditions

Pediatric ALL

Keywords

NeonatesElectrocardiogramUmbilical Vein Catheterization

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

ECG Monitoring

OTHER

ECG readings will be collected for neonatal patients who require or currently have UVC

Diagnostic Test: ECG

Interventions

ECGDIAGNOSTIC_TEST

An ECG collects superficial readings of heart activity

ECG Monitoring

Eligibility Criteria

Age1 Day - 45 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Neonate pediatric patient
  • Require or currently have UVC

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucille Packard Children's Hospital

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Central Study Contacts

Chynna Villanueva, BS, RN

CONTACT

6504986346chynnav@stanford.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor-Med Ctr Line

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 2, 2019

Study Start

August 25, 2020

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 1, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)