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Infants With Severe Acute Respiratory Distress Syndrome: The Prone Trial

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jul 31, 2026 → Jul 31, 2027
See other at-risk trials from Medical University of Vienna

Record History

  1. Primary completion pushed from Jul 31, 2026 to Jul 31, 2027 Completion pushed from Dec 31, 2026 to Dec 31, 2027v8 Show 1 more changeShow less
    • Completion pushed from Dec 31, 2026 to Dec 31, 2027
  2. Primary completion date: Aug 31, 2024 to Jul 31, 2026 Completion date: Dec 31, 2024 to Dec 31, 2026v7 Show 1 more changeShow less
    • Completion date: Dec 31, 2024 to Dec 31, 2026
  3. Re-verified, no change to tracked fieldsv6
  4. Primary completion date: Aug 31, 2023 to Aug 31, 2024 Completion date: Aug 31, 2024 to Dec 31, 2024 · Start date changed from estimate of May 15, 2022 to Jul 30, 2022v5 Show 2 more changesShow less
    • Completion date: Aug 31, 2024 to Dec 31, 2024
    • Start date changed from estimate of May 15, 2022 to Jul 30, 2022
  5. Start date: Nov 15, 2021 to May 15, 2022v4
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  1. Start date: Aug 15, 2021 to Nov 15, 2021 Eligibility criteria revisedv3 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Aug 1, 2021 to Aug 15, 2021 Eligibility criteria expanded, about 13 words · Study description expanded, about 12 wordsv2 Show 2 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Study description expanded, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The main objective is to determine the short-term effect of prone positioning in infants with infection-associated severe acute respiratory distress syndrome. The investigators compare oxygenation parameters and measurements from electrical impedance tomography (EIT) and lung ultrasonography (LUS) in mechanically ventilated infants in prone position versus supine position after surfactant administration.
Trial Details
NCT Number NCT05002478
Lead Sponsor Medical University of Vienna
Conditions Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS), Surfactant Dysfunction, Infant
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov