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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NCT06359522

PDA Occlusion Using NIRS

UNKNOWN
NAAges 0–3InterventionalTreatment
University of Louisville
~20 participants
Updated 2024-04-11 on ClinicalTrials.gov
What's tested:NIRS monitor

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measure changes in rScO2 and SrO2 after TCPC of a PDA and compare to baseline readings.
Measured over Baseline through 48 hours post procedure and daily for 5 days
+1 more outcome measured
Organ Perfusion Determined by Using NIRS Post Transcatheter PDA Occlusion or Medical Closure of PDA

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.

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Eligibility criteria

Inclusion

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

Infants with other hemodynamically significant congenital heart disease that could affect systemic blood flow
  • 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