Actively Recruiting
Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
Led by Nationwide Children's Hospital · Updated on 2025-03-30
240
Participants Needed
24
Research Sites
157 weeks
Total Duration
On this page
Sponsors
N
Nationwide Children's Hospital
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born between 22 weeks 0 days and 27 weeks 6 days gestation
- Admitted to a study neonatal intensive care unit (NICU)
- Birth weight of at least 700 grams
- Mechanically ventilated at the time of consent and randomization
- Patent ductus arteriosus (PDA) score of 6 or higher on echocardiogram
- Randomization can occur within 5 days of qualifying echocardiogram and when infant is 7 to 32 days old
You will not qualify if you...
- Life-threatening congenital defects except PDA and small heart septal defects
- Congenital lung abnormalities like restrictive lung disease
- Pharyngeal or airway anomalies such as tracheal stenosis or choanal atresia
- Treatment for acute abdominal conditions like necrotizing enterocolitis
- Planned surgery
- Active infection requiring treatment
- Chromosomal defects such as Trisomy 18
- Neuromuscular disorders
- Do not resuscitate order or limitation of intensive care considered
- Clinical instability making percutaneous PDA closure unsuitable unless improved before 30 days
- Pulmonary hypertension with right to left shunting over 33% of cardiac cycle
- Cardiac thrombus that could interfere with device placement
- PDA diameter larger than 4 mm or length smaller than 3 mm
- PDA score less than 6 on echocardiogram
- Parents or legal guardian do not speak English or Spanish
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
University of Alabama
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Withdrawn
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
5
Lucille Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
Withdrawn
6
UC Davis Children's Hospital
Sacramento, California, United States, 95817
Actively Recruiting
7
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Withdrawn
8
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
9
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
10
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
11
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
12
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Withdrawn
13
University of Minnesota, Masonic Children's Hospital
Minneapolis, Minnesota, United States, 55455
Withdrawn
14
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
15
Morgan Stanley Children's Hospital of New York-Presbyterian
New York, New York, United States, 10032
Withdrawn
16
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
17
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Withdrawn
18
Le Bonheur Children's Medical Center
Memphis, Tennessee, United States, 38103
Actively Recruiting
19
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Withdrawn
20
Medical City Children's Dallas
Dallas, Texas, United States, 75230
Actively Recruiting
21
UT Southwestern Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
Actively Recruiting
22
Texas Children's
Houston, Texas, United States, 77030
Actively Recruiting
23
Seattle Children's
Seattle, Washington, United States, 98105
Actively Recruiting
24
Children's Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
C
Carl H Backes
CONTACT
J
Jonathan Slaughter
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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