PDA Occlusion Using NIRS

NCT ID: NCT06359522

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-18
• Study Completion Date: 2025-09-30

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.

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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trancatheter occlusion

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

Group Type: OTHER

NIRS monitor

Intervention Type: DEVICE

NIRS monitoring data will be collected to determine organ perfusion.

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.

Group Type: OTHER

NIRS monitor

Intervention Type: DEVICE

NIRS monitoring data will be collected to determine organ perfusion.

Interventions

NIRS monitor

NIRS monitoring data will be collected to determine organ perfusion.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norton Healthcare

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Scott Duncan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Norton Children's Hospital

Louisville, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Scott D Duncan, MD

Role: CONTACT

scottd.duncan@louisville.edu

502-629-5283

Sarah P King, BA

Role: CONTACT

slpenn03@louisville.edu

502-629-5283

Facility Contacts

Scott D Duncan, MD

Role: primary

scottd.duncan@louisville.edu

502-629-5283

Janice E. Sullivan, MD

Role: backup

sully@louisville.edu

502-629-5283

Other Identifiers

22.0334

Identifier Type: -

Identifier Source: org_study_id