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

NCT05581927 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-05-06

No results posted yet for this study

Summary

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.

Conditions

  • Hypoxic- Ischemic Encephalopathy
  • Whole-Body Hypothermia
  • Brain Injury

Interventions

DEVICE

modified Whole-Body Hypothermia

patients were allocated to modified Whole-Body Hypothermia with normal base excess and blood pressure

DEVICE

standard Whole-Body Hypothermia

patients were allocated to standard Whole-Body Hypothermia

Sponsors & Collaborators

  • Children's Hospital of Chongqing Medical University

    collaborator OTHER

  • Children's Hospital of Suzhou

    collaborator UNKNOWN

  • Women and Children's Hospital of Chongqing

    collaborator UNKNOWN

  • Women and Children's Hospital of Guangxi

    collaborator UNKNOWN

  • People's hospital of Guangyuan

    collaborator UNKNOWN

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Hours
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05581927 on ClinicalTrials.gov