Monitoring organ perfusion in infants undergoing PDA closure
A Comparative Study of Medical Management vs Transcatheter PDA Occlusion Using Near-Infrared Spectroscopy
This study is testing how well two different methods of closing a heart condition in infants affect blood flow and oxygen levels in their brains and kidneys.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 0 Months to 3 Months |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT06359522 on ClinicalTrials.gov |
What this trial studies
This study is a prospective observational analysis of infants in the Norton Children's Hospital NICU who are undergoing either transcatheter PDA occlusion or medical closure of PDA. It aims to compare changes in organ perfusion, specifically cerebral and renal oxygen saturation, using Near-Infrared Spectroscopy (NIRS) monitoring. Patients will have NIRS probes placed prior to treatment to establish baseline readings, which will be monitored during and after the procedure for up to five days. The study will analyze the differences in regional oxygen saturation between the two treatment methods.
Who should consider this trial
Good fit: Ideal candidates include infants in the NICU with hemodynamically significant PDA requiring closure through either medical therapy or transcatheter occlusion.
Not a fit: Infants with other significant congenital heart diseases that could impact systemic blood flow may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective method for managing PDA in infants, potentially improving outcomes related to organ perfusion.
How similar studies have performed: Previous studies have indicated that NIRS monitoring can effectively assess organ perfusion, suggesting that this approach may yield valuable data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Louisville, Kentucky
- Norton Children's Hospital — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Study coordinator: Scott D Duncan, MD
- Email: scottd.duncan@louisville.edu
- Phone: 502-629-5283
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.