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Trancatheter occlusion for Patent Ductus Arteriosus

N/A

Recruiting

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 48 hours post procedure and daily for 5 days

Awards & highlights

Study Summary

This trial will observe babies in the NICU who undergo a procedure to close a heart defect called PDA. The study will compare two groups of babies - one group will have the procedure, and the

Who is the study for?

This trial is for newborns in the Norton Children's Hospital NICU with Patent Ductus Arteriosus (PDA), a heart condition. It aims to observe changes in blood oxygen levels during two types of PDA closure treatments.Check my eligibility

What is being tested?

The study compares the effects on organ oxygen supply between two PDA closure methods: transcatheter occlusion and medical therapy, using NIRS monitoring technology to measure regional oxygen saturation.See study design

What are the potential side effects?

Since this is an observational study focusing on monitoring techniques rather than new medications or interventions, specific side effects are not detailed; however, standard risks associated with medical procedures may apply.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 48 hours post procedure and daily for 5 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 48 hours post procedure and daily for 5 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 48 hours post procedure and daily for 5 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measure changes in rScO2 and SrO2 after TCPC of a PDA and compare to baseline readings.

Measure changes in rScO2 and SrO2 after medical closure of PDA with Tylenol.

Secondary outcome measures

Compare rates of co-morbid conditions between the two groups such as but not limited to necrotizing enterocolitis, feedings intolerance, or failed to extubate within 5 days post treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Trancatheter occlusionExperimental Treatment1 Intervention

Patients who are being treated with transcatheter occlusion for PDA closure are eligible to participate in this study for NIRS monitoring.

Group II: Medical closureExperimental Treatment1 Intervention

Patients who are being treated with tylenol or indomethacin for medical closure of their PDA are eligible to participate in this study for NIRS monitoring.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

339 Previous Clinical Trials

76,660 Total Patients Enrolled

Norton HealthcareOTHER

15 Previous Clinical Trials

2,878 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the necessary criteria to participate in this medical study?

"Candidates must have a patent ductus arteriosus and fall within the age range of 0 to 3 months to be eligible for participation. A maximum of 20 individuals will be accepted into this study."

Answered by AI

Are there any available slots for patients to participate in this clinical trial?

"Indeed, information from clinicaltrials.gov reveals that this medical investigation is actively seeking candidates. The trial was originally posted on April 18th, 2023 and last modified on April 5th, 2024. A total of 20 participants are sought from a single study site."

Answered by AI

What is the current number of subjects participating in this investigation?

"Yes, the details on clinicaltrials.gov show that this trial is currently open for participant recruitment. The initial posting date was 4/18/2023 with the latest update made on 4/5/2024. The study aims to enroll 20 participants at a single location."

Answered by AI