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

Trial Summary

What is the purpose of this trial?

Our study will be a prospective observational study of all patients in the Norton Children's Hospital NICU (Neonatal Intensive Care Unit) who undergo a transcatheter PDA occlusion or medical closure of PDA to compare the two populations regarding changes in organ perfusion determined by using NIRS monitoring to follow the regional saturation of oxygen (rSO2) of the cerebral and renal regions. We suspect that medical treatment will have no significant change in rSO2 as described in previous literature. We also suspect that transcatheter occlusion will have minimal effects on rSO2 and be comparable to medical therapy.

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.

Is transcatheter PDA closure safe for humans?

Transcatheter closure of patent ductus arteriosus (PDA) has been studied for over 20 years and is generally considered safe, with most cases replacing the need for surgery. Studies have focused on the rate of adverse events (unwanted side effects) and have shown that it is a widely accepted procedure with a good safety profile. ^{1 2 3 4 5}

How is the treatment for Patent Ductus Arteriosus Occlusion different from other treatments?

Transcatheter PDA Occlusion is unique because it involves a minimally invasive procedure using a catheter (a thin tube) to close the ductus arteriosus, which can be especially beneficial for small or preterm infants, improving lung function without the need for open surgery. ^{5 6 7 8 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety of percutaneous patent ductus arteriosus closure: an unselected multicenter population experience. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Transvenous occlusion of patent ductus arteriosus in 56 consecutive dogs. [2012]

3. Germany pubmed.ncbi.nlm.nih.gov

Safety and efficacy of percutaneous patent ductus arteriosus closure: a multicenter Egyptian experience. [2022]

4. Pakistan pubmed.ncbi.nlm.nih.gov

Percutaneous transcatheter PDA device closure in infancy. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Transcatheter Patent Ductus Arteriosus Occlusion in Small Infants. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

A comprehensive program for preterm infants with patent ductus arteriosus. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Coil occlusion of PDA in patients younger than 1 year: risk factors for adverse events. [2012]

8. United States pubmed.ncbi.nlm.nih.gov

A novel technique for transcatheter patent ductus arteriosus closure in extremely preterm infants using commercially available technology. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Ductal spasm during performance of transcatheter ductal occlusion. [2014]