Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants

Part of paid clinical trials in Birmingham, Alabama.

Sponsor: Nationwide Children's Hospital
Study ID: NCT05547165
Status: Recruiting

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Conditions

Ductus Arteriosus, Patent

Eligibility Criteria

Sex: ALL
Age: 7 Days - 32 Days
Healthy Volunteers: Not accepted

Interventions

Percutaneous Patent Ductus Arteriosus Closure (PPC) — DEVICE
Infants in this group will undergo catheter-based PPC closure ≤48 hours following randomization and within 7-days of qualifying ECHO. All participants assigned to PPC will receive the Amplatzer Piccolo™ Occluder which will be implanted within the duct (intraductal placement). The Piccolo™ occluder is approved by the US FDA for this purpose.
Responsive Management Intervention — COMBINATION_PRODUCT
Interventional PDA-closure, including PPC or surgical ligation and post-randomization pharmacologic (NSAID or acetaminophen) (enteral or intravenous) PDA treatment, are not allowed unless secondary treatment thresholds (see below) are met. Healthcare decisions for Responsive Management will be made at the discretion of the treatment team, while the infant is carefully monitored for any decline in status that may be attributed to the presence of PDA, in which case, Secondary Intervention (described below) may be considered. Despite widespread acceptance of responsive PDA management, no consensus definition exists. The following Responsive Management interventions are permitted but not required per clinician discretion: 1) fluid restriction between 120-140 mL/kg/day; 2) diuretics (per local practice); 3) increases in positive end-expiratory pressure (PEEP).
Echocardiogram, cardiac — DIAGNOSTIC_TEST
An echocardiogram, also known as "ECHO", is an ultrasound image of the heart. Echocardiography is a common test used for the diagnosis and management of cardiac diseases or conditions.

Study Details

Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward.

Key Dates

Start date: Feb 21, 2023
Status verified: Mar 2025
Primary completion: Feb 28, 2026
Completion: Feb 28, 2026

Study Design

Enrollment: 240 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Active Comparator: Primary Comparator
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.
Other: Secondary Intervention
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.

Primary Outcome Measure

Number of days free of ventilatory support requirement (ventilator-free days; VFDs) [ Time Frame: 30 days post-randomization ]

Central Contacts

Carl H Backes
16143556729
[email protected]
Jonathan Slaughter
16143556643
[email protected]

Locations (24)

Facility	City	State	ZIP	Site coordinators
University of Alabama	Birmingham	Alabama	35294	Hope Arnold, MD [email protected] 225-571-4656 Stephen Clark, MD [email protected] 205-934-3460 Andrea Kane, MD (PRINCIPAL_INVESTIGATOR)
Arkansas Children's Hospital	Little Rock	Arkansas	72202	Megha Sharma, MD [email protected] Sherry Courtney, MD [email protected]
Cedars-Sinai Medical Center	Los Angeles	California	90048	Evan Zahn, MD [email protected] Kurlen Payton, MD [email protected] Michelle Allen-Sharpley, MD (SUB_INVESTIGATOR) Myriam Almeida-Jones, MD (SUB_INVESTIGATOR)
Children's Hospital Los Angeles	Los Angeles	California	90027	-
Lucille Packard Children's Hospital at Stanford	Palo Alto	California	94304	-
UC Davis Children's Hospital	Sacramento	California	95817	Frank Ing, MD [email protected]
Children's Hospital Colorado	Aurora	Colorado	80045	-
Joe DiMaggio Children's Hospital	Hollywood	Florida	33021	Peter Guyton, MD [email protected] Bruce Schulman, MD [email protected]
Orlando Health	Orlando	Florida	32806	Michael McMahan, MD [email protected] Michael Farias, MD [email protected]
Ann and Robert H. Lurie Children's Hospital	Chicago	Illinois	60611	Nicolas Porta, MD [email protected] Alan Nugent, MD [email protected]
Boston Children's Hospital	Boston	Massachusetts	02115	Philip Levy, MD [email protected]
C.S. Mott Children's Hospital	Ann Arbor	Michigan	48109	-
University of Minnesota, Masonic Children's Hospital	Minneapolis	Minnesota	55455	-
St. Louis Children's Hospital	St Louis	Missouri	63110	Daisuke Kobayashi, MD [email protected] Andy Glatz, MD [email protected] Manish Aggarwal, MD (SUB_INVESTIGATOR)
Morgan Stanley Children's Hospital of New York-Presbyterian	New York	New York	10032	-
Nationwide Children's Hospital	Columbus	Ohio	43205	Jonathan Slaughter, MD [email protected] Carl Backes, MD [email protected]
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	-
Le Bonheur Children's Medical Center	Memphis	Tennessee	38103	Mark Weems, MD [email protected]
Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee	37232	-
Medical City Children's Dallas	Dallas	Texas	75230	Vivian Dimas, MD [email protected] Carrie Herbert, MD [email protected]
UT Southwestern Children's Medical Center of Dallas	Dallas	Texas	75235	Sushmita Yallapragada, MD [email protected] Suren Reddy, MD [email protected]
Texas Children's	Houston	Texas	77030	Sharada Gowda, MD [email protected] 732-925-4563 Gary Stapleton [email protected]
Seattle Children's	Seattle	Washington	98105	Kirti Upadhyay, MD [email protected] Brian Morray, MD [email protected]
Children's Wisconsin	Milwaukee	Wisconsin	53226	Vijay Karody, MD [email protected] Todd Gudausky, MD [email protected]

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