Management of the PDA Trial



Status:Recruiting
Conditions:Cardiology, Women's Studies
Therapuetic Areas:Cardiology / Vascular Diseases, Reproductive
Healthy:No
Age Range:Any
Updated:3/13/2019
Start Date:December 3, 2018
End Date:July 31, 2024
Contact:Matthew Laughon, MD, MPH
Email:matt_laughon@med.unc.edu
Phone:984-974-5063

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Management of the Patent Ductus Arteriosus in Premature Infants Trial (PDA Trial)

Estimate the risks and benefits of active treatment versus expectant management of a
symptomatic patent ductus arteriosus (sPDA) in premature infants.

This is a pragmatic randomized multicenter, effectiveness study comparing active treatment of
a symptomatic patent ductus arteriosus (sPDA) to expectant management. We hypothesize in
premature infants with a sPDA, expectant management reduces the incidence proportion of death
or BPD by 10% (from 50% to 40%) when compared to active treatment.

Participants with a sPDA allocated to the active treatment arm will receive intravenous
administration of indomethacin or ibuprofen (depending on center preference). The decision to
ligate will be left to the clinical team. Participants with a sPDA allocated to the expectant
management arm will receive supportive care at the clinical team's discretion and will
receive indomethacin/ibuprofen or ligation if the infant develops cardiopulmonary compromise.
The decision to ligate will be left to the clinical team.

The primary endpoint for the study will be death or BPD (as assessed by the physiologic
definition) at 36 weeks postmenstrual age (PMA).

Inclusion Criteria:

- Postnatal age 48 hours -21 days

- Infant 22 0/7 to 28 6/7 weeks gestation at birth

- sPDA, as defined as:

1. Mild, Moderate, or Severe Clinical Criteria with Small or Moderate size PDA on
echocardiogram

2. Mild or Moderate Clinical Criteria with Large PDA on echocardiogram

Exclusion Criteria:

- Cardiopulmonary compromise

- Known congenital heart disease (besides atrial septal defect or ventricular septal
defect)

- Known pulmonary malformation (e.g. congenital lobar emphysema, congenital pulmonary
adenomatous malformation)

- Any condition which, in the opinion of the investigator, would preclude enrollment
We found this trial at
16
sites
Palo Alto, California 94304
Principal Investigator: Krisa P. Van Meurs, MD
Phone: 650-723-5711
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: David P Carlton, MD
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Waldemar A. Carlo, MD
Phone: 205-934-4680
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Myra Wyckoff, MD
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Jon E. Tyson, MD MPH
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Edward F. Bell, MD
Phone: 319-356-4006
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Providence, Rhode Island 02905
Principal Investigator: Abbot R Laptook, MD
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Carl T D'Angio, MD
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Bradley A. Yoder, MD
Phone: 801-581-7052
University of Utah Research is a major component in the life of the U benefiting...
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Kristi L. Watterberg, MD
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Cincinnati, Ohio 45267
Principal Investigator: Brenda Poindexter, MD
Phone: 513-636-0252
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Cleveland, Ohio 44106
Principal Investigator: Michele C. Walsh, MD MS
Phone: 216-844-3387
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Columbus, Ohio 43205
Principal Investigator: Pablo Sanchez, MD
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Eric Eichenwald, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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