What side effects are associated with this type of intervention?

The most common treatment for Patent Ductus Arteriosus (PDA) similar to the PICCOLO trial is percutaneous closure using devices like the Amplatzer. Known side effects of this procedure include bleeding, infection, device embolization, and residual shunt. Other treatments, such as medication (e.g., NSAIDs like ibuprofen or indomethacin), can cause renal impairment, gastrointestinal issues, and bleeding. Surgical ligation, another treatment option, carries risks of infection, vocal cord paralysis, and thoracic duct injury.

What prior FDA approvals exist?

The FDA has approved several treatments for Patent Ductus Arteriosus (PDA), particularly focusing on minimally invasive procedures. One notable approval is the PICCOLO device, which is used for percutaneous closure of the ductus arteriosus. This device offers a less invasive alternative to surgical ligation, providing a new standard of care for closing the PDA in preterm infants. Other treatments include medications like indomethacin and ibuprofen, which are used to encourage the closure of the ductus arteriosus in neonates. However, the PICCOLO device represents a significant advancement in the percutaneous management of PDA.

What other types of research exist?

Promising, novel alternatives to PICCOLO for the treatment of Patent Ductus Arteriosus in 2024 include supportive management with medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or indomethacin, which help close the ductus arteriosus. Additionally, advancements in catheter-based techniques and new devices for minimally invasive closure are being explored. These alternatives aim to provide effective treatment while minimizing invasiveness and potential complications.

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Device

PPC vs Observation for Patent Ductus Arteriosus in Infants (PIVOTAL Trial)

N/A

Recruiting

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

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

Must have

EPIs born between 22-weeks+0 days (220/7 wks) and 27-weeks+6 days (276/7 wks) gestation, inclusive

Be younger than 18 years old

Must not have

Chromosomal defects (e.g., Trisomy 18)

Evidence of cardiac thrombus that might interfere with device placement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 34 - 36 weeks post-menstrual age

Awards & highlights

Summary

This trial is a randomized controlled trial, which is the best way to determine if one treatment is better than the other.

Who is the study for?

This trial is for preterm infants with Patent Ductus Arteriosus (PDA), a heart condition present at birth. Eligible infants must be in the NICU, on mechanical ventilation, and between 7-32 days old with a birth weight of ≥700 grams. They should have a specific PDA severity score on an echocardiogram but no chromosomal defects, neuromuscular disorders, congenital lung abnormalities or life-threatening conditions.Check my eligibility

What is being tested?

The study compares two treatments for PDA: percutaneous closure using the PICCOLO device versus supportive management with medications. It's designed to see which method is more effective for these low-weight infants and could potentially set new care standards.See study design

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information; however, as it involves an invasive procedure (PPC) using PICCOLO or medication management, risks may include infection, bleeding, or reactions to anesthesia/medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My baby was born between 22 and 27 weeks of pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a genetic condition like Trisomy 18.

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I have a blood clot in my heart that could affect medical device placement.

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My infant is under a do not resuscitate order or we are considering limiting intensive care.

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My parents or guardian do not speak English or Spanish.

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My infant is scheduled for surgery.

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I have a throat or airway abnormality.

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I have a disorder affecting my muscles and nerves.

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I was born with a lung condition.

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I am currently being treated for an infection.

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I am receiving treatment for a severe abdominal condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 34 - 36 weeks post-menstrual age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~34 - 36 weeks post-menstrual age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 34 - 36 weeks post-menstrual age for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Ventilator - respiratory equipment

Secondary outcome measures

Abnormal cardiac remodeling

Baby Care Questionnaire (BCQ)

Oxygen

+18 more

Other outcome measures

Determine whether neurodevelopment at 3-4 months CA is mediated by improved neurodevelopmental profiles at 34-36 weeks PMA.

Evaluation of effect modifiers on primary

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Secondary InterventionExperimental Treatment2 Interventions

Sub-group of patients initially randomized to Responsive Management who may suffer a decline in health status that can be attributed to the presence of a hemodynamically significant patent ductus arteriosus (HSPDA). These patients, upon meeting pre-specified clinical criteria, will undergo active treatment via Percutaneous Patent Ductus Arteriosus Closure (PPC) as in the active comparator arm.

Group II: Primary ComparatorActive Control3 Interventions

Interventional groups that subject will be randomly assigned to include Percutaneous Patent Ductus Arteriosus Closure (PPC) or Responsive Management. Those assigned to PPC will undergo active intervention to close a hemodynamically significant patent ductus arteriosus (HSPDA) whereas those assigned to Responsive Management will be treated to manage the symptoms of the HSPDA and permit natural closure over time.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Patent Ductus Arteriosus (PDA) is commonly treated through either medication or surgical intervention. Medications like NSAIDs (e.g., ibuprofen or indomethacin) work by inhibiting prostaglandin synthesis, which helps close the ductus arteriosus. However, when medications are ineffective or not suitable, percutaneous closure using devices like the FDA-approved PICCOLO device is an option. This minimally invasive procedure involves inserting a catheter to place a closure device in the ductus arteriosus, effectively sealing the opening. This method is significant for PDA patients as it offers a less invasive alternative to open-heart surgery, reducing recovery time and associated risks.

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