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Recruiting NCT06359522

PDA Occlusion Using NIRS

Trial Parameters

Condition Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDA
Sponsor University of Louisville
Study Type INTERVENTIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 0 Months
Max Age 3 Months
Start Date 2023-04-18
Completion 2025-03-31
Interventions
NIRS monitor

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.

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

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