RECRUITING

PDA Occlusion Using NIRS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Our study will be a prospective observational study of all patients in the Norton Children's Hospital NICU (Neonatal Intensive Care Unit) who undergo a transcatheter PDA occlusion or medical closure of PDA to compare the two populations regarding changes in organ perfusion determined by using NIRS monitoring to follow the regional saturation of oxygen (rSO2) of the cerebral and renal regions. We suspect that medical treatment will have no significant change in rSO2 as described in previous literature. We also suspect that transcatheter occlusion will have minimal effects on rSO2 and be comparable to medical therapy.

Official Title

A Comparative Study of Medical Management vs Transcatheter PDA Occlusion Using Near-Infrared Spectroscopy

Quick Facts

Study Start:2023-04-18
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06359522

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Months to 3 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Infants in the Norton Children's NICU with hsPDA deemed to require closure either through medical therapy or transcatheter occlusion by the primary NICU care team.
  2. * Parents or Legal Guardian provide written consent for the infant to participate in this study
  1. * Infants with other hemodynamically significant congenital heart disease that could affect systemic blood flow

Contacts and Locations

Study Contact

Scott D Duncan, MD
CONTACT
502-629-5283
scottd.duncan@louisville.edu
Sarah P King, BA
CONTACT
502-629-5283
slpenn03@louisville.edu

Study Locations (Sites)

Norton Children's Hospital
Louisville, Kentucky, 40202
United States

Collaborators and Investigators

Sponsor: University of Louisville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-18
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2023-04-18
Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDA