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Neurostimulation to Improve NOWS Outcomes

Study acronym: SPROUT
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv31
  2. Collaborators: 3 to 5v30
  3. Primary completion date: Dec 25, 2024 to Jan 31, 2025
    • Study completion date: Aug 31, 2025 to Jan 31, 2027
    v29
  4. Re-verified, no change to tracked fieldsv28
  5. Primary completion date: Jan 31, 2025 to Dec 25, 2024
    • Study completion date: Feb 2027 to Aug 31, 2025
    • Start date: Jul 26, 2022 to Jul 27, 2022
    v27
Show 25 earlier versionsHide 25 earlier versions
  1. 2 versions Re-verified since Mar 3, 2025, no change to tracked fieldsv25-v26
  2. Trial status: Recruiting to Active, Not Recruitingv24 Show 4 more changesShow less
    • Enrollment target: estimated 80 to confirmed 52
    • Eligibility criteria expanded, about 6 words
    • Site details revised at 3 of 3 sites
    • Collaborators: 2 to 3
  3. Primary completion date: Mar 2025 to Jan 31, 2025
    • Study completion date: Apr 2027 to Feb 2027
    v23
  4. Re-verified, no change to tracked fieldsv22
  5. Primary completion date: May 2025 to Mar 2025
    • Study completion date: May 2027 to Apr 2027
    v21
  6. 2 versions Re-verified since Aug 5, 2024, no change to tracked fieldsv19-v20
  7. Primary completion date: Nov 2025 to May 2025
    • Study completion date: Nov 2027 to May 2027
    v18
  8. Site contacts updated at 1 of 3 sitesv17
  9. Site details revised at 1 of 3 sitesv16
  10. Primary completion date: Aug 2025 to Nov 2025
    • Study completion date: Aug 2027 to Nov 2027
    v15
  11. Study completion date: Dec 2025 to Aug 2027v14
  12. Site details revised at 1 of 3 sitesv13
  13. Primary completion date: Aug 2024 to Aug 2025v12 Show 4 more changesShow less
    • Study completion date: Sep 2024 to Dec 2025
    • Eligibility criteria shortened, about 63 words
    • Secondary endpoints: 3 to 5
    • Study description expanded, about 86 words
  14. Study sites: 2 to 3v11
  15. Site contacts updated at 1 of 2 sitesv10
  16. Secondary endpoints revised (3)v9
  17. Primary completion date: Aug 2023 to Aug 2024
    • Study completion date: Sep 2023 to Sep 2024
    • Site contacts updated at 1 of 2 sites
    v8
  18. Primary completion date: Aug 1, 2023 to Aug 2023
    • Study completion date: Sep 1, 2023 to Sep 2023
    v7
  19. Re-verified, no change to tracked fieldsv6
  20. Study sites: 1 to 2
    • Study title shortened, about 2 words
    v5
  21. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 1, 2022 to Jul 26, 2022
    • Secondary endpoints revised (3)
    v4
  22. Start date: Apr 15, 2022 to Aug 1, 2022
    • Primary completion date: Apr 15, 2023 to Aug 1, 2023
    • Study completion date: May 15, 2023 to Sep 1, 2023
    v3
  23. Start date: Feb 1, 2022 to Apr 15, 2022v2 Show 8 more changesShow less
    • Primary endpoints revised (2)
    • Primary completion date: Feb 1, 2023 to Apr 15, 2023
    • Study completion date: Mar 1, 2023 to May 15, 2023
    • Interventions: Roo tAN Therapy System (Device), Sham Roo tAN Therapy System (Device) to Sham Sparrow Fledging Therapy System (Device), Sparrow Fledging Therapy System (Device)
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints: 6 to 3
    • Study description shortened, about 25 words
    • Collaborators expanded, about 11 words
  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 objective of this study is to determine if tAN therapy can reduce the median number of days of oral morphine administered to an infant after start of treatment.
Trial Details
NCT Number NCT05129020
Lead Sponsor Spark Biomedical, Inc.
Collaborators: Medical University of South Carolina, University of Texas Southwestern Medical Center, The University of Texas Health Science Center at San Antonio, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
Conditions
(from sponsor)		 Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
Related terms Neonatal Abstinence Syndrome, Substance Withdrawal Syndrome
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov