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Management of the PDA Trial

Study acronym: PDA
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Results first posted: May 12, 2026
    • Enrollment target: estimated 836 to confirmed 482
    • Secondary endpoints revised (10)
    • Primary endpoint revised
    v13
  2. Primary completion date changed from estimate of Apr 18, 2025 to Mar 2, 2025v12
  3. Primary completion date: Mar 2027 to Apr 18, 2025v11 Show 4 more changesShow less
    • Start date: Dec 3, 2018 to Feb 22, 2019
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Mar 2029 to May 30, 2027
    • Site details revised at 19 of 19 sites
  4. Enrollment target: 1116 to 836v10
  5. Study sites: 16 to 19
    • Collaborators expanded, about 12 words
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Mar 2023 to Mar 2027
    • Study completion date: Mar 2023 to Mar 2029
    v8
  2. Primary completion date: May 30, 2022 to Mar 2023
    • Study completion date: Jul 31, 2024 to Mar 2023
    v7
  3. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 16 of 16 sites
    v6
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 16 of 16 sites
    v5
  5. Site details revised at 9 of 16 sitesv4
  6. Re-verified, no change to tracked fieldsv3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 30, 2018 to Dec 3, 2018
    • Site details revised at 16 of 16 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Estimate the risks and benefits of active treatment versus expectant management of a symptomatic patent ductus arteriosus (sPDA) in premature infants.
Trial Details
NCT Number NCT03456336
Lead Sponsor NICHD Neonatal Research Network
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Infant, Premature, Patent Ductus Arteriosus, Infant, Newborn, Diseases, Patent Ductus Arteriosus After Premature Birth
Related terms Ductus Arteriosus, Patent, Infant, Newborn, Diseases, Premature Birth
Enrollment 482 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov