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

Summary

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.

Conditions

• Ductus Arteriosus, Patent

Interventions

DEVICE

Percutaneous Patent Ductus Arteriosus Closure (PPC)

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.

COMBINATION_PRODUCT

Responsive Management Intervention

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).

DIAGNOSTIC_TEST

Echocardiogram, cardiac

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.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Abbott

  collaborator INDUSTRY

• University of Pittsburgh

  collaborator OTHER

• University of Bristol

  collaborator OTHER

• Dartmouth College

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• Emory University

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Nationwide Children's Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Days

Max Age

32 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-21

Primary Completion

2026-02-28

Completion

2026-02-28

FDA Device

Yes

Countries

• United States

Study Locations