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Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint revised Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 90 to confirmed 69 · Primary completion date changed from estimate of Dec 2024 to Oct 1, 2024 · 3 morev9 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 90 to confirmed 69
    • Primary completion date changed from estimate of Dec 2024 to Oct 1, 2024
    • Completion date: Dec 2026 to Dec 1, 2026
    • Secondary endpoint revised
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  2. Study description expanded, about 42 wordsv8 See this version in full on ClinicalTrials.gov ↗
  3. Primary completion date: Dec 2022 to Dec 2024 Completion date: Dec 2023 to Dec 2026v7 Show 1 more changeShow less
    • Completion date: Dec 2023 to Dec 2026
  4. Re-verified, no change to tracked fieldsv6
  5. Study description shortened, about 14 wordsv5 See this version in full on ClinicalTrials.gov ↗
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 1, 2018 to Feb 21, 2018 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Feb 1, 2018 to Feb 21, 2018
    • Site details revised
  2. Primary completion date: Dec 2018 to Dec 2022 Start date: Sep 1, 2017 to Feb 1, 2018 · Completion date: Dec 2020 to Dec 2023 · Study description expanded, about 345 wordsv3 Show 3 more changesShow less
    • Start date: Sep 1, 2017 to Feb 1, 2018
    • Completion date: Dec 2020 to Dec 2023
    • Study description expanded, about 345 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Mar 2018 to Dec 2018 Start date: Mar 2017 to Sep 1, 2017 · Completion date: Dec 2018 to Dec 2020 · Study description expanded, about 196 wordsv2 Show 3 more changesShow less
    • Start date: Mar 2017 to Sep 1, 2017
    • Completion date: Dec 2018 to Dec 2020
    • Study description expanded, about 196 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to show non-inferiority between two medications used for medical treatment of withdrawal seen in Neonatal Abstinence Syndrome (NAS), Clonidine and Morphine Sulfate (used in routine care) on length of treatment for NAS .
Trial Details
NCT Number NCT03092011
Lead Sponsor The Cooper Health System
Conditions Neonatal Abstinence Syndrome
Enrollment 69 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov