NIRS Monitoring for Patent Ductus Arteriosus

Overseen By Sarah P King, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: Congenital heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two treatments for closing a condition known as patent ductus arteriosus (PDA) in infants. PDA occurs when a small blood vessel in the heart doesn't close properly after birth. The trial will observe how these treatments affect oxygen levels in the brain and kidneys. Infants in the NICU (Neonatal Intensive Care Unit) needing PDA treatment, either through medication or a procedure called transcatheter occlusion (PDA Occlusion), may be eligible to join. Parents must provide consent for their infant's participation.

As an unphased trial, this study offers infants a unique opportunity to potentially benefit from innovative treatments while contributing to valuable medical research.

Do I need to stop my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that NIRS monitoring is safe for assessing organ perfusion in PDA treatments?

Previous studies have shown that closing a patent ductus arteriosus (PDA) using a small tube (transcatheter) is safe and effective, particularly for infants weighing less than 10 kg. The procedure carries a low rate of complications, though some can still occur. Specifically, 9.3% of patients experienced problems during the study, but serious issues were less common.

Medications like Tylenol or indomethacin have a history of safely closing a PDA. These treatments have been used before and are generally considered safe for certain cases.

Both options, using a small tube or medications, have safety records suggesting they are well-tolerated. However, like any medical procedure or treatment, there is always a risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NIRS monitoring in the treatment of Patent Ductus Arteriosus (PDA) because it offers a new way to evaluate the effectiveness of both transcatheter occlusion and medical closure methods. Unlike traditional monitoring techniques, NIRS (Near-Infrared Spectroscopy) provides real-time insights into tissue oxygenation, potentially improving patient outcomes by allowing for more precise adjustments during treatment. This approach could lead to quicker and more accurate assessments, helping to tailor treatments to individual needs and minimize complications. By integrating NIRS monitoring, clinicians hope to enhance the safety and success rates of both transcatheter and medical closure strategies for PDA.

What evidence suggests that this trial's treatments could be effective for PDA closure?

This trial will compare two methods for closing a patent ductus arteriosus (PDA). Research has shown that closing a PDA using a catheter, which participants in the transcatheter occlusion arm of this trial may receive, is a safe and effective treatment. Studies have found that about 90% of infants successfully have their PDA closed with this method. Long-term results indicate that this treatment also improves heart function and symptoms in teenagers and adults.

Alternatively, participants in the medical closure arm of this trial will receive medications like Tylenol or indomethacin to close a PDA. This traditional approach can be effective, but its success often depends on the size and specific features of the PDA. In some cases, the ductus may not close completely with medication alone. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Parents or Legal Guardian provide written consent for the infant to participate in this study

My infant needs treatment for a heart issue (hsPDA) in the Norton Children's NICU.

Exclusion Criteria

My infant has a serious heart condition affecting blood flow.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Monitoring

NIRS monitoring is placed up to 24 hours prior to treatment to establish baseline levels

1 day

Continuous monitoring

Treatment

Participants undergo either transcatheter PDA occlusion or medical closure with Tylenol or indomethacin

1 day

1 visit (in-person)

Post-Treatment Monitoring

NIRS monitoring continues for 5 days post-treatment to observe changes in rSO2

5 days

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 days

Daily monitoring

What Are the Treatments Tested in This Trial?

Interventions

• PDA Occlusion

Trial Overview 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.

How Is the Trial Designed?

Group I: Trancatheter occlusion Experimental Treatment 1 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 closure Experimental Treatment 1 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.

PDA Occlusion is already approved in United States, European Union for the following indications:

Approved in United States as PDA Occlusion for:

• Hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants

Approved in European Union as PDA Occlusion for:

• Hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Norton Healthcare

Collaborator

Trials

17

Recruited

2,900+

Published Research Related to This Trial

Transcatheter patent ductus arteriosus (PDA) occlusion was successfully performed in 80% of the 20 small infants studied, with a specific measurement (minimum PDA diameter/length ratio <0.4) predicting technical success.

After the procedure, 80% of patients showed improved respiratory status at 7 days, indicating that the intervention may enhance lung function in symptomatic infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Patent Ductus Arteriosus Occlusion in Small Infants. Schwartz, MC., Nykanen, D., Winner, LH., et al.[2018]

Transcatheter coil occlusion of patent ductus arteriosus (PDA) is feasible in infants under 12 months, with a clinical success rate of 91% in a study of 32 patients.

Major adverse events were more likely in patients under 6 months of age and weighing less than 6 kg, particularly those with a minimum duct diameter greater than 3.5 mm, indicating these factors may increase procedural risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coil occlusion of PDA in patients younger than 1 year: risk factors for adverse events. Tomita, H., Uemura, S., Haneda, N., et al.[2012]

In a review of 331 transcatheter PDA occlusions, significant ductal spasm was identified in seven premature infants, highlighting the need for awareness of this phenomenon during procedures to prevent occlusion failure.

All patients experienced successful occlusion with no significant complications, indicating that transcatheter PDA occlusion is a safe and effective intervention even in very young patients with restrictive PDAs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ductal spasm during performance of transcatheter ductal occlusion. Batlivala, SP., Glatz, AC., Gillespie, MJ., et al.[2014]

Transcatheter closure of patent ductus arteriosus (PDA) was successful in 95% of the 308 procedures performed, indicating high efficacy for this minimally invasive treatment, especially in pediatric patients aged 6 months to 6 years.

While the overall complication rate was low at 5%, with only 2% being major complications, younger age and lower body weight were linked to higher complication rates, highlighting the need for careful management in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of percutaneous patent ductus arteriosus closure: a multicenter Egyptian experience. Nour, A., Abdelrazik, Y., Huessin, S., et al.[2022]

In a study of 55 infants undergoing transcatheter closure of patent ductus arteriosus (PDA), 96.1% of the procedures were successful, indicating high efficacy for this intervention.

Despite the high success rate, there were notable complications, including local vascular issues in 21.8% of cases and serious events like cardiac arrest in one patient, highlighting the need for careful monitoring during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous transcatheter PDA device closure in infancy. Ullah, M., Sultan, M., Akhtar, K., et al.[2019]

A multicenter study involving 496 transcatheter patent ductus arteriosus (PDA) closures showed a low overall adverse event rate of 9%, with only 2% classified as high severity, indicating that the procedure is generally safe.

Younger patients had a higher rate of adverse events, and coil closures were associated with more complications compared to device closures, suggesting that the choice of closure method may impact safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of percutaneous patent ductus arteriosus closure: an unselected multicenter population experience. El-Said, HG., Bratincsak, A., Foerster, SR., et al.[2021]

Transcatheter closure of patent ductus arteriosus (PDA) in extremely preterm infants (born at less than 32 weeks gestation) was successfully performed in a study of six infants, achieving complete closure without major complications.

The technique utilized the Amplatzer Vascular Plug II and combined echocardiography with limited fluoroscopy, avoiding arterial access, which is crucial for the safety of these fragile patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel technique for transcatheter patent ductus arteriosus closure in extremely preterm infants using commercially available technology. Zahn, EM., Nevin, P., Simmons, C., et al.[2015]

Transvenous catheter occlusion of patent ductus arteriosus (PDA) was successfully performed in 54 out of 56 dogs (96.4%), demonstrating high efficacy across a range of ductal sizes.

The procedure had a low mortality rate of 1.7% and a major complication rate of 7.0%, indicating it is a safe treatment option for dogs, including those weighing less than 2.5 kg.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transvenous occlusion of patent ductus arteriosus in 56 consecutive dogs. Blossom, JE., Bright, JM., Griffiths, LG.[2012]

Transcatheter PDA closure (TCPC) is a safe and effective treatment for extremely low birth weight (ELBW) infants with significant patent ductus arteriosus, as demonstrated in a study involving 134 infants, including those as small as 640 grams.

The implementation of a comprehensive follow-up strategy through the Memphis PDA Clinic has led to improved outcomes, including faster recovery from respiratory support, better tolerance of feedings, and overall growth, contributing to shorter hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive program for preterm infants with patent ductus arteriosus. Apalodimas, L., Waller Iii, BR., Philip, R., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4988101/

Follow-Up Results of Device Occlusion of Patent Ductus ... The catheterization was successful in 393 (97.2%) patients and in 11 (2.7%) cases, PDA was not closed after catheterization due to the tiny size of PDA in eight ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.022776

Trend and Outcomes for Surgical Versus Transcatheter ... Comparison of cost and clinical outcome between transcatheter coil occlusion and surgical closure of isolated patent ductus arteriosus.

3. nature.com nature.com/articles/s41372-023-01741-1

3-year follow-up of a prospective, multicenter study of the ... This follow-up study demonstrates high rates of PDA closure, low serious complication rates, and survival > 95% at 3 years.

4. jpedres.org jpedres.org/articles/transcatheter-ductus-arteriosus-closure-with-various-devices-in-the-pediatric-patient-group-and-long-term-outcomes-experience-from-a-single-center/jpr.galenos.2024.69094

Transcatheter Ductus Arteriosus Closure with Various ... In our study, ADO-II was successfully used in 107 patients (33.4%) with a 99% success rate for transcatheter PDA closure. Overall, the coil ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772930325013080

SCAI Position Statement on Transcatheter Occlusion of ... Closure of a hemodynamically significant PDA (hsPDA) may benefit certain preterm infants. Historically, pharmacotherapy treatment has been the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8897530/

Safety and efficacy of percutaneous patent ductus ... Although transcatheter closure of PDA is considered to be effective procedure with low complications rate, however, complications should be anticipated and ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36995404/

Safety and Short-Term Outcomes for Infants < 2.5 kg ... Transcatheter PDA closure in small infants can be performed with excellent short-term outcomes and safety across institutions with variable case volume.

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.113.000424

Safety of Percutaneous Patent Ductus Arteriosus Closure The incidence of any AEs among patients undergoing transcatheter PDA closure was 9.3% (95% CI 6.4 to 11.5), with a rate of high‐severity AEs of ...