Recruiting

NIRS

Sponsor:

University of Louisville

Code:

NCT06359522

Conditions

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

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

NIRS monitor

Study Details

Brief summary:

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.

Conditions

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

Study ID

NCT06359522

Start date

Apr 18, 2023

Status verified date

Apr, 2024

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • Parents or Legal Guardian provide written consent for the infant to participate in this study

Exclusion Criteria:

  • Infants with other hemodynamically significant congenital heart disease that could affect systemic blood flow

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Trancatheter occlusion

Patients who are being treated with transcatheter occlusion for PDA closure are eligible to participate in this study for NIRS monitoring.

other: Medical closure

Patients who are being treated with tylenol or indomethacin for medical closure of their PDA are eligible to participate in this study for NIRS monitoring.

Interventions

NIRS monitor

NIRS monitoring data will be collected to determine organ perfusion.

Primary outcome measure

  • Measure changes in rScO2 and SrO2 after TCPC of a PDA and compare to baseline readings. [ Time Frame: Baseline through 48 hours post procedure and daily for 5 days ]
  • Measure changes in rScO2 and SrO2 after medical closure of PDA with Tylenol. [ Time Frame: Baseline through 48 hours post procedure and daily for 5 days ]

Central Contacts and Locations

Central contacts

Scott D Duncan, MD

502-629-5283scottd.duncan@louisville.edu

Sarah P King, BA

502-629-5283slpenn03@louisville.edu

Locations

Norton Children's Hospital

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Scott D Duncan, MD

502-629-5283scottd.duncan@louisville.edu

Janice E. Sullivan, MD

502-629-5283sully@louisville.edu

More Information

Sponsor

University of Louisville

Last update posted

Apr 11, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Louisville on 2024-04-11.