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Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part I

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 1 month later Aug 15, 2026 → Sep 22, 2027
See other at-risk trials from University of Alabama at Birmingham

Record History

  1. Primary and study completion pushed from Aug 15, 2026 to Sep 22, 2027 Primary endpoints: details revised at 1 of 1 entry · Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 3 of 8 entries · 1 more Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 3 of 8 entries
    • Collaborators: details revised at 1 of 1 entry
  2. Primary and study completion dates: Aug 15, 2025 to Aug 15, 2026v19
  3. Primary and study completion dates: Aug 15, 2024 to Aug 15, 2025v18
  4. Primary and study completion dates: Aug 15, 2023 to Aug 15, 2024v17
  5. Primary completion date: Aug 15, 2022 to Aug 15, 2023 Completion date: Jun 24, 2023 to Aug 15, 2023v16 Show 1 more changeShow less
    • Completion date: Jun 24, 2023 to Aug 15, 2023
Show 14 earlier versionsHide 14 earlier versions
  1. Re-verified, no change to tracked fieldsv15
  2. Primary completion date: Aug 15, 2020 to Aug 15, 2022 Completion date: Jun 24, 2021 to Jun 24, 2023v14 Show 1 more changeShow less
    • Completion date: Jun 24, 2021 to Jun 24, 2023
  3. Primary completion date: Oct 2018 to Aug 15, 2020 Trial status: Recruiting to Active, Not Recruiting · Completion date: Oct 2019 to Jun 24, 2021 · Site details revisedv13 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Oct 2019 to Jun 24, 2021
    • Site details revised
  4. Phase: Phase 4 to Not applicable Primary completion date: Oct 2017 to Oct 2018 · Completion date: Oct 2017 to Oct 2019 · Interventions: Partial head covering plastic bag during resuscitation (Procedure), Torso bag during resuscitation (Procedure) to Resuscitation-partial-head plastic bag (Procedure), Resuscitation-torso plastic bag (Procedure)v12 Show 3 more changesShow less
    • Primary completion date: Oct 2017 to Oct 2018
    • Completion date: Oct 2017 to Oct 2019
    • Interventions: Partial head covering plastic bag during resuscitation (Procedure), Torso bag during resuscitation (Procedure) to Resuscitation-partial-head plastic bag (Procedure), Resuscitation-torso plastic bag (Procedure)
  5. Primary and study completion dates: Feb 2017 to Oct 2017v11
  6. Primary completion date: Aug 2016 to Feb 2017v10
  7. 3 versions Re-verified since Jun 29, 2015, no change to tracked fieldsv7-v9
  8. Primary completion date: Aug 2014 to Aug 2016 Completion date: Feb 2015 to Feb 2017v6 Show 1 more changeShow less
    • Completion date: Feb 2015 to Feb 2017
  9. Re-verified, no change to tracked fieldsv5
  10. Primary completion date: Aug 2013 to Aug 2014 Completion date: Feb 2014 to Feb 2015v4 Show 1 more changeShow less
    • Completion date: Feb 2014 to Feb 2015
  11. Primary completion date: Aug 2012 to Aug 2013 Primary endpoint revised · Completion date: Feb 2013 to Feb 2014 · Secondary endpoints: 16 to 8 · 1 morev3 Show 4 more changesShow less
    • Primary endpoint revised
    • Completion date: Feb 2013 to Feb 2014
    • Secondary endpoints: 16 to 8
    • Study description shortened, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  12. Trial status: Not Yet Recruiting to Recruiting Start date: May 2012 to Jun 2012 · Site details revised · Collaborator revisedv2 Show 3 more changesShow less
    • Start date: May 2012 to Jun 2012
    • Site details revised
    • Collaborator revised

    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 overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.
Trial Details
NCT Number NCT01604317
Lead Sponsor University of Alabama at Birmingham
Collaborators: Children's Health System, Alabama
Conditions Hypothermia, Immature Newborn
Enrollment 182 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov