Management of the PDA Trial
PDA
Management of the Patent Ductus Arteriosus in Premature Infants Trial (PDA Trial)
4 other identifiers
interventional
482
1 country
19
Brief Summary
Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2019
Longer than P75 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedStudy Start
First participant enrolled
February 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2025
CompletedResults Posted
Study results publicly available
May 12, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2027
ExpectedMay 12, 2026
April 1, 2026
6 years
February 19, 2018
March 12, 2026
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks PMA
A composite outcome for infants who were diagnosed with physiologic bronchopulmonary dysplasia (BPD) or died by 36 weeks postmenstrual age (PMA). Physiologic BPD is determined using existing Neonatal Research Network Generic Database criteria at 36 weeks PMA. Infants alive an in hospital are classified based on respiratory status at 36 weeks PMA or by a room air weaning challenge performed between 36 and 37 weeks PMA. Infants who are transferred or discharged before 36 weeks are classified based on the support they are receiving at that time. Infants who died before 36 weeks PMA are not assessed for BPD. Deaths include all-cause deaths between randomization and 36 weeks PMA.
Randomization to 36 weeks PMA
Secondary Outcomes (10)
Mortality at 36 Weeks PMA
birth to 36 week postmenstrual age
Mortality Before Discharge
birth to 120 days of life
Bronchopulmonary Dysplasia - Physiological Test
birth to 36 week postmenstrual age
Bronchopulmonary Dysplasia - NIH Consensus Definition
birth to 36 week postmenstrual age
Necrotizing Enterocolitis (NEC) at 36 Weeks PMA
birth to 36 weeks post menstrual age
- +5 more secondary outcomes
Other Outcomes (6)
Necrotizing Enterocolitis (NEC) at Status (2 Years)
26 months corrected age
Retinopathy of Prematurity at Status (2 Years)
26 months corrected age
Weight at Status (2 Years)
26 months corrected age
- +3 more other outcomes
Study Arms (2)
Active Treatment Group
ACTIVE COMPARATORInfants assigned to the active treatment group will receive indomethacin or ibuprofen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin or ibuprofen will be left to the center, however, infants may only receive one or the other.
Expectant Management Group
ACTIVE COMPARATORInfants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs.
Interventions
Infants assigned to the active treatment group will receive indomethacin or ibuprofen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin or ibuprofen will be left to the center, however, infants may only receive one or the other. If the infant receives both, it will be considered a protocol violation.
Infants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs.
Eligibility Criteria
You may qualify if:
- Postnatal age 48 hours -21 days
- Infant 22 0/7 to 28 6/7 weeks gestation at birth
- sPDA, as defined as:
- Mild, Moderate, or Severe Clinical Criteria with Small or Moderate size PDA on echocardiogram
- Mild or Moderate Clinical Criteria with Large PDA on echocardiogram
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Stanford University
Palo Alto, California, 94304, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123, United States
Emory University
Atlanta, Georgia, 30303, United States
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Mississippi Medical Center - Children's of Mississippi
Jackson, Mississippi, 39216, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
University of Rochester
Rochester, New York, 14642, United States
RTI International
Durham, North Carolina, 27705, United States
Duke University
Durham, North Carolina, 27710, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Brown University - Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Related Publications (1)
Laughon MM, Thomas SM, Watterberg KL, Kennedy KA, Keszler M, Ambalavanan N, Davis AS, Slaughter JL, Guillet R, Colaizy TT, Cotten CM, Dhawan MA, Bose CL, Talbert J, Smucny S, Benitz WE, Rysavy MA, Ohls RK, Baserga MC, DeMauro SB, Jaleel M, Jackson WM, Carlo WA, Puopolo KM, Hibbs AM, Katheria A, Sanchez PJ, D'Angio CT, Patel RM, Johnson BA, Chock VY, Bhatt AJ, Merhar SL, Moore R, Laptook AR, Ghavam S, Fuller J, Vyas-Read S, Kicklighter SD, Steinbrekera B, Anderson K, Chandrasekharan PK, Wyckoff MH, Montoya C, Das A, Do B, Chang S, Higgins RD, Walsh MC; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Expectant Management vs Medication for Patent Ductus Arteriosus in Preterm Infants: The PDA Randomized Clinical Trial. JAMA. 2026 Feb 17;335(7):588-599. doi: 10.1001/jama.2025.23330.
PMID: 41364689DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Matthew Laughon
- Organization
- University of North Carolina at Chapel Hill
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2018
First Posted
March 7, 2018
Study Start
February 22, 2019
Primary Completion
March 2, 2025
Study Completion (Estimated)
May 30, 2027
Last Updated
May 12, 2026
Results First Posted
May 12, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
Per NIH Data Sharing Plan