PDA Occlusion Using NIRS
A Comparative Study of Medical Management vs Transcatheter PDA Occlusion Using Near-Infrared Spectroscopy
University of Louisville
20 participants
Apr 18, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 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 Criteria1
- Infants with other hemodynamically significant congenital heart disease that could affect systemic blood flow
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Interventions
NIRS monitoring data will be collected to determine organ perfusion.
Locations(1)
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NCT06359522