PDA Occlusion Using NIRS

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

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.

Study Overview

• Status: Recruiting
• Conditions: Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDA
• Intervention / Treatment: Device: NIRS monitor

Detailed Description

Informed Consent will be obtained prior to initiation of the study protocol. NIRS Monitoring (Cerebral and Renal) will be placed with skin probes on the scalp and abdomen up to 24 hours prior to initiation of treatment either through medical therapy (Tylenol or indomethacin) or transcatheter occlusion. These values will be used to create an average baseline for the patient. NIRS will be left on during treatment/procedure and for 5 days after treatment to monitor any changes during or after treatment of the PDA. Changes will be compared to baseline readings.

NIRS monitoring will be done with INOVS 7100 Regional Oximeter from Medtronic (https://www.medtronic.com/covidien/en-us/products/cerebral-somatic-oximetry/invos-7100 system.html). Data collection will be done through chart review and pulling logged data from the NIRS monitoring unit. Data to be collected will include type of treatment, gestational age, patient birth weight, patient weight at time of treatment, and rSO2 (Cerebral and Regional) rSO2 variation will be addressed by calculating Coefficients of Variance at 5min epochs which has been shown to decrease the effects of normal variation.

Standardized time points will be compared between the two groups as follows:

• Data to be collected will include type of treatment, gestational age, patient birth weight, patient weight at time of treatment, and rSO2 (Cerebral and Regional)
• rSO2 variation will b e addressed by calculating Coefficients of Variance at 5min epochs which has been shown to decrease the effects of normal variation (10).

• Standardized time points will be compared between the two groups as follows:

  1. Baseline Levels: 24 hours prior to treatment
  2. During the Procedure: during initiation of procedure, 5min after device placed,10 min post device placement, 30min post device placement and 1 hour post placement
  3. Levels at 12 hours post treatment, until 48 hours post and then daily until monitoring is discontinued.
  4. Arterial O2 Saturations, FiO2 %, mode of ventilation will be recorded at the above time points as well and fractionated
• Statistician will analyze data collected

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott D Duncan, MD; Phone Number: 502-629-5283; Email: scottd.duncan@louisville.edu
• Study Contact Backup: Name: Sarah P King, BA; Phone Number: 502-629-5283; Email: slpenn03@louisville.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • Norton Children's Hospital
      • Contact: Scott D Duncan, MD; Phone Number: 502-629-5283; Email: scottd.duncan@louisville.edu
      • Contact: Janice E. Sullivan, MD; Phone Number: 502-629-5283; Email: sully@louisville.edu
      • Sub-Investigator: Joshua D Kurtz, MD
      • Sub-Investigator: Joshua Lee, MD
      • Sub-Investigator: John N Juneau, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Trancatheter occlusion; Patients who are being treated with transcatheter occlusion for PDA closure are eligible to participate in this study for NIRS monitoring.	Device: NIRS monitor; NIRS monitoring data will be collected to determine organ perfusion.
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.	Device: NIRS monitor; NIRS monitoring data will be collected to determine organ perfusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure changes in rScO2 and SrO2 after TCPC of a PDA and compare to baseline readings.	NIRS cerebral and regional monitoring	Baseline through 48 hours post procedure and daily for 5 days
Measure changes in rScO2 and SrO2 after medical closure of PDA with Tylenol.	NIRS cerebral and regional monitoring	Baseline through 48 hours post procedure and daily for 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare rates of co-morbid conditions between the two groups such as but not limited to necrotizing enterocolitis, feedings intolerance, or failed to extubate within 5 days post treatment.	Medical outcomes	Baseline through 5 days post-treatment

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: Norton Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 22.0334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No