PDA Occlusion Using NIRS
This study is looking at how different ways to close a patent ductus arteriosus (PDA) — a common heart problem in premature babies — affect blood flow to the brain and other organs. Researchers will compare babies who have their PDA closed with a procedure called transcatheter PDA occlusion to those who receive medicine like Tylenol. They will use a special monitor called NIRS (Near-Infrared Spectroscopy) to measure oxygen levels in the brain and kidneys before, during, and after treatment. The goal is to see if either treatment causes significant changes in these oxygen levels. We expect that both medical treatment and transcatheter occlusion will have minimal effects on these oxygen levels. This study is for infants aged 0 to 3 months in the Norton Children's NICU who need PDA closure. Currently, the status of this study is unclear.
- Study design
- This is an observational study involving 20 infants. It compares two groups of infants receiving different PDA treatments.
- What's involved
- Your infant will have NIRS monitors placed on their head and abdomen up to 24 hours before treatment. These monitors will stay on during treatment and for 5 days afterward.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your infant will be monitored for 5 days after their PDA treatment.
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PDA Occlusion Using NIRS
At a glance
Conditions
NCT06359522
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Norton Children's Hospital
Louisville, Kentuckystudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
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Inclusion
Exclusion
What this trial measures
- Measure changes in rScO2 and SrO2 after TCPC of a PDA and compare to baseline readings.Baseline through 48 hours post procedure and daily for 5 days
NIRS cerebral and regional monitoring
- Measure changes in rScO2 and SrO2 after medical closure of PDA with Tylenol.Baseline through 48 hours post procedure and daily for 5 days
NIRS cerebral and regional monitoring