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"Prapela® SVS Incubator Pad for Apnea of Prematurity

Study acronym: Prapela AOP
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 7, 2025 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Primary endpoint revised · Enrollment target: 120 to 140 · Study sites: 0 to 2 · 2 morev4 Show 5 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 120 to 140
    • Study sites: 0 to 2
    • Start date changed from estimate of Dec 1, 2024 to Feb 6, 2025
    • Secondary endpoints: 2 to 4

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Sep 15, 2024 to Dec 1, 2024 Primary completion date: Jun 1, 2026 to Oct 1, 2026v3 Show 1 more changeShow less
    • Primary completion date: Jun 1, 2026 to Oct 1, 2026
  3. Start date: May 15, 2024 to Sep 15, 2024v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay.
Trial Details
NCT Number NCT06374147
Lead Sponsor Tufts Medical Center
Collaborators: University of Alabama at Birmingham
Conditions Apnea of Prematurity
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov