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NCT05581927

Whole-Body Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy(HIE)

Withdrawn NA Last updated 6 May 2023
What this trial tests

NA trial testing modified Whole-Body Hypothermia in Hypoxic- Ischemic Encephalopathy. Withdrawn.

Timeline
1 October 2022
Primary endpoint
31 December 2024
31 December 2024

Quick facts

Lead sponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University
PhaseNA
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Start date1 October 2022
Primary completion31 December 2024
Estimated completion31 December 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Who can join

Adults 0 Hours to 24 Hours, any sex, with Hypoxic- Ischemic Encephalopathy or Whole-Body Hypothermia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Among term infants, hypoxic-ischemic encephalopathy due to acute perinatal asphyxia remains an important cause of brain injury in childhood. Infants with moderate encephalopathy have a 10 percent risk of death, and those who survive have a 30 percent risk of disabilities. Sixty percent of infants with severe encephalopathy die, and many, if not all, survivors are disabled. Whole-body hypothermia reduces the risk of death or disability in infants with moderate or severe hypoxic-ischemic encephalopathy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Translational Potential of Stem Cell-based Therapies in the Treatment of Neonatal Hypoxic-ischemic Brain Injury.
    Gebala P, Janowska J, Sypecka J. · · 2025 · PMID 40471437 · DOI 10.1007/s12015-025-10905-9

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