Using ECG to guide umbilical vein catheter placement in neonates
Umbilical Vessel Catheterization Under ECG Monitoring and Guidance
This study is testing whether using ECG monitoring can help doctors place umbilical venous catheters more accurately in newborns with acute lymphoblastic leukemia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 1 Day to 45 Days |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT03898596 on ClinicalTrials.gov |
What this trial studies
This study focuses on improving the placement of umbilical venous catheters (UVC) in neonates by utilizing electrocardiogram (ECG) monitoring for guidance. The traditional methods of catheter placement often lack precision and can lead to misplacement in critical areas, posing risks to infants. By employing ECG tracings, the study aims to provide a non-invasive and continuous monitoring approach to ensure accurate catheter placement. This could enhance the safety and effectiveness of UVC procedures in pediatric patients with acute lymphoblastic leukemia (ALL).
Who should consider this trial
Good fit: Ideal candidates for this study are neonate pediatric patients weighing between 2 to 6 kg who require or currently have a UVC.
Not a fit: Patients who are clinically unstable or do not have parental consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risks associated with UVC misplacement in critically ill neonates.
How similar studies have performed: While the use of ECG for catheter placement is a novel approach, similar studies have shown promise in improving procedural accuracy in other medical contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California
- Lucille Packard Children's Hospital — Palo Alto, California, United States (Recruiting)
Study contacts
- Study coordinator: Chynna Villanueva, BS, RN
- Email: chynnav@stanford.edu
- Phone: 6504986346
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.