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RECRUITING
NCT06359522
NA

PDA Occlusion Using NIRS

Sponsor: University of Louisville

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

0 Months - 3 Months

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-04-18

Completion Date

2025-09-30

Last Updated

2024-04-11

Healthy Volunteers

No

Interventions

DEVICE

NIRS monitor

NIRS monitoring data will be collected to determine organ perfusion.

Locations (1)

Norton Children's Hospital

Louisville, Kentucky, United States