PDA Occlusion Using NIRS

NCT06359522 | Recruiting FDA Device

• 1 other identifier: 22.0334
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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.

  Baseline through 5 days post-treatment

Study Arms (2)

Trancatheter occlusion

OTHER

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

Device: NIRS monitor

Medical closure

OTHER

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

Interventions

NIRS monitor DEVICE

NIRS monitoring data will be collected to determine organ perfusion.

Medical closure; Trancatheter occlusion

Eligibility Criteria

• Age: 0 Months - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Louisville: lead
• Norton Healthcare: collaborator

Study Sites (1)

Norton Children's Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

Central Study Contacts

Scott D Duncan, MD

CONTACT

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

Sarah P King, BA

CONTACT

502-629-5283; slpenn03@louisville.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients who are being treated for PDA closure either via transcatheter occlusion or medical closure as part of routine care are eligible for this study.

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 11, 2024
• Study Start: April 18, 2023
• Primary Completion: March 31, 2025
• Study Completion: September 30, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

US (1)