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The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Sep 2025 to Oct 2026
    • Study completion date: Nov 2025 to Nov 2026
    v9
  2. Primary completion date: Dec 2024 to Sep 2025
    • Study completion date: Dec 2024 to Nov 2025
    v8
  3. Primary completion date: Dec 2023 to Dec 2024
    • Study completion date: Jan 2024 to Dec 2024
    v7
  4. Primary completion date: Jun 2023 to Dec 2023
    • Study completion date: Sep 2023 to Jan 2024
    v6
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 15, 2022 to Sep 16, 2022
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Aug 2022 to Oct 15, 2022
    • Interventions: womb sound recordings (Other) to Womb sound recordings (Other)
    • Study description expanded, about 4 words
    v4
  2. Start date: Jun 2022 to Aug 2022v3
  3. Primary completion date: Jun 2024 to Jun 2023
    • Study completion date: Sep 2024 to Sep 2023
    • Study arms: 1 to 2
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants.
Trial Details
NCT Number NCT05298748
Lead Sponsor Case Western Reserve University
Conditions
(from sponsor)		 Apnea of Prematurity, Intermittent Hypoxemia, Bradycardia
Related terms Apnea, Bradycardia
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov