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Music Intervention for Preterm Birth

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened Start date changed from estimate of Sep 15, 2026 to Sep 29, 2026 · Site details revised at 2 of 2 sites · Eligibility criteria expanded, about 5 words Show 3 more changesShow less
    • Start date changed from estimate of Sep 15, 2026 to Sep 29, 2026
    • Site details revised at 2 of 2 sites
    • Eligibility criteria expanded, about 5 words
  2. Start date: Jul 26, 2026 to Sep 15, 2026v18
  3. Start date: May 26, 2026 to Jul 26, 2026v17
  4. Start date: Mar 12, 2026 to May 26, 2026v16
  5. Start date: Apr 16, 2023 to Mar 12, 2026 Trial status: Recruiting to Not Yet Recruiting · Primary completion date: Nov 2027 to Jul 30, 2027 · Completion date: Nov 30, 2027 to Aug 29, 2027 · 1 morev15 Show 4 more changesShow less
    • Trial status: Recruiting to Not Yet Recruiting
    • Primary completion date: Nov 2027 to Jul 30, 2027
    • Completion date: Nov 30, 2027 to Aug 29, 2027
    • Site details revised at 2 of 2 sites
Show 13 earlier versionsHide 13 earlier versions
  1. Trial status: Suspended to Recruiting Primary completion date: May 30, 2029 to Nov 2027 · Completion date: Aug 29, 2029 to Nov 30, 2027 · Start date: Jan 7, 2025 to Apr 16, 2023 · 1 morev14 Show 4 more changesShow less
    • Primary completion date: May 30, 2029 to Nov 2027
    • Completion date: Aug 29, 2029 to Nov 30, 2027
    • Start date: Jan 7, 2025 to Apr 16, 2023
    • Study sites revised (2)

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Recruiting to Suspended Sponsor's reason: Loss of funding Primary completion date: May 30, 2026 to May 30, 2029 · Completion date: Aug 29, 2026 to Aug 29, 2029 · Site details revised at 2 of 2 sitesv13 Show 3 more changesShow less
    • Primary completion date: May 30, 2026 to May 30, 2029
    • Completion date: Aug 29, 2026 to Aug 29, 2029
    • Site details revised at 2 of 2 sites
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 2024 to Jan 7, 2025 · Site details revised at 2 of 2 sitesv12 Show 2 more changesShow less
    • Start date changed from estimate of Dec 2024 to Jan 7, 2025
    • Site details revised at 2 of 2 sites
  4. Start date: Nov 6, 2024 to Dec 2024v11
  5. Primary completion date: May 2025 to May 30, 2026 Start date: Jan 23, 2024 to Nov 6, 2024 · Trial status: Active, Not Recruiting to Not Yet Recruiting · Completion date: Aug 2025 to Aug 29, 2026 · 1 morev10 Show 4 more changesShow less
    • Start date: Jan 23, 2024 to Nov 6, 2024
    • Trial status: Active, Not Recruiting to Not Yet Recruiting
    • Completion date: Aug 2025 to Aug 29, 2026
    • Site contacts updated at 1 of 2 sites
  6. Trial status: Recruiting to Active, Not Recruiting Site details revised at 2 of 2 sitesv9 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  7. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 2023 to Jan 23, 2024 · Site details revised at 2 of 2 sitesv8 Show 2 more changesShow less
    • Start date changed from estimate of Nov 2023 to Jan 23, 2024
    • Site details revised at 2 of 2 sites
  8. Re-verified, no change to tracked fieldsv7
  9. Collaborators: 2 to 3v6 See this version in full on ClinicalTrials.gov ↗
  10. 2 versions Re-verified since Oct 26, 2023, no change to tracked fieldsv4-v5
  11. Primary completion date: Sep 2026 to May 2025 Completion date: Sep 2027 to Aug 2025 · Start date: Oct 2023 to Nov 2023 · Interventions: Music Intervention (MI) (Behavioral), Verbal Intervention (VI) (Behavioral) to Music Intervention (MI) (Behavioral), Sham Control (SC) (Other) · 2 morev3 Show 5 more changesShow less
    • Completion date: Sep 2027 to Aug 2025
    • Start date: Oct 2023 to Nov 2023
    • Interventions: Music Intervention (MI) (Behavioral), Verbal Intervention (VI) (Behavioral) to Music Intervention (MI) (Behavioral), Sham Control (SC) (Other)
    • Site contacts updated at 1 of 2 sites
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  12. Start date: Aug 2023 to Oct 2023v2
  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.
This study will test a music intervention (MI) versus a sham control (SC) arm which only includes a verbal intervention, to determine if the effects of the music intervention will reduce the biological impact of chronic stress among pregnant Black women, reduce preterm birth, and improve infant outcomes.
Trial Details
NCT Number NCT05945264
Lead Sponsor Columbia University
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD), Emory University, Icahn School of Medicine at Mount Sinai
Conditions Preterm Birth
Enrollment 142 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov