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

Status: Recruiting
Location: See all (24) locations...
Intervention Type: Combination product, Device, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7 days
Maximum Age: 1 month
Healthy Volunteers: f
View:

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

• Admitted to a study NICU

• Birth weight ≥700-grams

• Mechanically ventilated at time of consent and randomization

• HSPDA (PDA Score ≥6) noted on echocardiogram (ECHO)

• Randomization is able to be performed within 5 days of the qualifying ECHO and when infant is 7-32 days postnatal

Locations
United States
Alabama
University of Alabama
RECRUITING
Birmingham
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Children's Hospital Los Angeles
WITHDRAWN
Los Angeles
Lucille Packard Children's Hospital at Stanford
WITHDRAWN
Palo Alto
UC Davis Children's Hospital
RECRUITING
Sacramento
Colorado
Children's Hospital Colorado
WITHDRAWN
Aurora
Florida
Joe DiMaggio Children's Hospital
RECRUITING
Hollywood
Orlando Health
RECRUITING
Orlando
Illinois
Ann and Robert H. Lurie Children's Hospital
RECRUITING
Chicago
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Michigan
C.S. Mott Children's Hospital
WITHDRAWN
Ann Arbor
Minnesota
University of Minnesota, Masonic Children's Hospital
WITHDRAWN
Minneapolis
Missouri
St. Louis Children's Hospital
RECRUITING
St Louis
New York
Morgan Stanley Children's Hospital of New York-Presbyterian
WITHDRAWN
New York
Ohio
Nationwide Children's Hospital
RECRUITING
Columbus
Pennsylvania
Children's Hospital of Philadelphia
WITHDRAWN
Philadelphia
Tennessee
Le Bonheur Children's Medical Center
RECRUITING
Memphis
Monroe Carell Jr. Children's Hospital at Vanderbilt
WITHDRAWN
Nashville
Texas
Medical City Children's Dallas
RECRUITING
Dallas
UT Southwestern Children's Medical Center of Dallas
RECRUITING
Dallas
Texas Children's
RECRUITING
Houston
Washington
Seattle Children's
RECRUITING
Seattle
Wisconsin
Children's Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Carl H Backes
carl.backes@nationwidechildrens.org
16143556729
Backup
Jonathan Slaughter
jonathan.slaughter@nationwidechildrens.org
16143556643
Time Frame
Start Date: 2023-02-21
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 240
Treatments
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.
Sponsors
Collaborators: Dartmouth College, Emory University, University of Iowa, Cedars-Sinai Medical Center, Children's Hospital Los Angeles, University of Pittsburgh, University of Bristol, National Institutes of Health (NIH), Abbott, National Heart, Lung, and Blood Institute (NHLBI)
Leads: Nationwide Children's Hospital

This content was sourced from clinicaltrials.gov