ECG-Guided Umbilical Vessel Catheterization for Acute Lymphoblastic Leukemia

Overseen By Chynna Villanueva, BS, RN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: No consent, Clinically unstable

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 15 minutes

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to make umbilical venous catheter (UVC) placement safer for newborns with acute lymphoblastic leukemia. Researchers plan to use ECG, a test that checks heart activity, to guide and monitor catheter placement more accurately. The goal is to prevent the catheter from accidentally entering areas like the liver or spleen, which can be harmful. This trial targets newborns weighing between 2 to 6 kg who need or already have a UVC. As an unphased trial, it offers a unique opportunity to contribute to safer medical procedures for newborns.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that ECG-guided umbilical vessel catheterization is safe for neonatal patients?

Research has shown that ECG (electrocardiogram) monitoring can enhance the safety of umbilical vessel catheterization. This method improves catheter placement accuracy, reducing the risk of incorrect positioning in areas like the liver or spleen, which can be harmful.

Umbilical vessel catheterization, used to administer medicines and fluids to newborns, is generally safe and effective. Although specific data on side effects when using ECG for guidance is lacking, this method aims to improve safety by ensuring correct catheter positioning.

Overall, ECG-guided catheter placement is considered a promising approach to making this important procedure safer for infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using ECG-guided umbilical vessel catheterization for treating neonatal patients with acute lymphoblastic leukemia because it offers a more precise method of catheter placement. Unlike traditional techniques that rely on anatomical landmarks or X-ray guidance, this approach uses real-time ECG monitoring to ensure accurate catheter positioning. This precision can potentially reduce complications and improve the effectiveness of the treatment, making it a promising development in the care of these young patients.

What evidence suggests that ECG-guided umbilical vessel catheterization is effective for acute lymphoblastic leukemia?

Research has shown that using an electrocardiogram (ECG) to guide catheter placement in umbilical vessels improves accuracy. In this trial, participants will receive ECG monitoring to ensure correct placement of umbilical vessel catheters. Traditional methods sometimes lead to incorrect placement, causing complications. ECG monitoring helps place the catheter accurately, reducing the risk of dangerous placement in areas like the liver or spleen. Early findings suggest that ECG-guided placement offers a safer and more reliable method for newborns needing this procedure. Overall, this approach aims to enhance safety and effectiveness in critical infant care. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for newborn pediatric patients who weigh between 2 to 6 kilograms and either require or currently have an umbilical venous catheter (UVC). To participate, they must have consent from parents. Clinically unstable infants cannot take part in this study.

Inclusion Criteria

My weight is between 2 and 6 kilograms.

My child is a newborn.

Require or currently have UVC

Exclusion Criteria

Patients who are clinically unstable

Participants who do not consent or have parental consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

ECG readings are collected for neonatal patients with UVC to monitor catheter placement

15 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after ECG monitoring

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ECG
• Umbilical Vessel Catheterization

Trial Overview The study is testing the use of electrocardiogram (ECG) monitoring as a non-invasive method to place and continuously monitor the position of UVCs in neonates, aiming to reduce misplacement risks associated with traditional methods.

How Is the Trial Designed?

Group I: ECG Monitoring Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. withpower.com withpower.com/trial/ecg-guided-umbilical-vessel-catheterization-for-acute-lymphoblastic-leukemia-dad17

ECG-Guided Umbilical Vessel Catheterization for Acute ... This N/A medical study run by Stanford University is evaluating whether Umbilical Vessel Catheterization will have tolerable side effects & efficacy for ...

2. clinicaltrial.be clinicaltrial.be/en/details/64441?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Umbilical Vessel Catheterization Under ECG Monitoring ... Our study aims at using a more non-invasive means of placing and continuously monitoring catheter placement using superficial electrocardiogram ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK549869/

Umbilical Vein Catheterization - StatPearls - NCBI Bookshelf Umbilical vein catheterization can provide a safe and effective route for intravenous delivery of medications and fluids during resuscitation. This activity ...

4. publications.aap.org publications.aap.org/pediatrics/article/145/Supplement_3/S243/34470/Selection-and-Insertion-of-Vascular-Access-Devices

Selection and Insertion of Vascular Access Devices in ... This systematic review provides the first synthesis of the breadth of evidence available for the selection and insertion of VADs in ...

5. smartpatients.com smartpatients.com/trials/NCT03898596

Umbilical Vessel Catheterization Under ECG Monitoring ... Our study aims at using a more non-invasive means of placing and continuously monitoring catheter placement using superficial electrocardiogram ...