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Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy

This study has been completed.
Sponsor:
Collaborator:
Medical University Innsbruck, Austria
Information provided by:
Zhengzhou University
ClinicalTrials.gov Identifier:
NCT00817401
First received: January 2, 2009
Last updated: January 5, 2009
Last verified: January 2009
History of Changes
  Purpose

Perinatal asphyxia-induced brain injury is one of the most common causes of morbidity and mortality in term and preterm neonates. Birth asphyxia accounts for 23% of neonatal deaths globally and survivors suffer from long term neurological disability and impairment. Although many neuroprotective strategies appeared promising in animal models, most of them were not feasible and effective in human newborns. However, hypothermia was reported not to be effective if introduced beyond and thus should be introduced within 6 hrs after birth.Applying this selection criterion naturally would deprive many patients of the opportunity of hypothermia treatment.


Condition Intervention Phase
Hypoxic-Ischemic Encephalopathy
 Device: hypothermia
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Systemic Hypothermia on Neonatal Hypoxic-Ischemic Encephalopathy

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Further study details as provided by Zhengzhou University:

Primary Outcome Measures:
  • Mortality and disability rate. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: July 2002
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: hypothermia
    For the systemic hypothermia treatment (TS Med 200, Germany), the infants were nursed under an open unit, covered only by a diaper and a thin linen, loosing heat to the environment and to a cooling mat¬tress which was perfused by circulating liquid at a variable temperature. The rectal temperature was targeted at 33.5 °C (range of 33 to 34 °C) and was meant to be achieved within 60 min. The body temperature was checked every 10 min during induction hypothermia and every hour during the remaining period of cooling. The duration of hypothermia was 72 hrs. Rewarming was started by stopping the cooling system. The infant was meant to reach a 36.5°C rectal temperature in 6 hrs after stopping cooling to prevent rebound hyperthermia.
    Other Name: TS Med 200, Germany
Detailed Description:

Hypoxic-ischemic encephalopathy of the newborn infant remains a significant socio-economic health problem worldwide. Moderate to severe HIE of newborn infants is associated with a high rate of death or long-term disabilities. Historically, treatment has been purely supportive including stabilizing cardio-respiratory functions and treating convulsions. Recent multi-center trials assessing the effects of hypothermia demonstrated improved outcome in term neonates with moderate hypoxic-ischemic encephalopathy (HIE). However, hypothermia was not effective beyond 6 hrs after brain injury. The aim of this study was to investigate whether systemic hypothermia induced up to 10 hrs after birth would improve the neurodevelopmental outcome at 18 months in infants with moderate or severe HIE.

  Eligibility

Ages Eligible for Study:   up to 10 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Gestation age ≥37 weeks and body weight >2500g.

  2. with one of the following factors:

    1. Apgar score<5 at 5min;
    2. Assisted respiration >3min due to respiratory distress;
    3. pH≤7.1 of cord or arterial blood within 60min after birth;
    4. clinical manifestation of encephalopathy during the first 10 hrs of life.

Exclusion Criteria:

  1. Major congenital abnormalities;
  2. Head trauma or skull fracture causing major intracranial hemorrhage;
  3. Mild HIE;
  4. Financial problems of the parents;
  5. Lack of permanent address;
  6. Postnatal age > 10 hrs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817401

Locations
China, Henan
NICU, the Third Affiliated Hospital, Zhengzhou University
Zhengzhou, Henan, China, 450052
Sponsors and Collaborators
Zhengzhou University
Medical University Innsbruck, Austria
Investigators
Study Director: Changlian Zhu, MD, PhD Zhengzhou University
  More Information

No publications provided

Responsible Party: Professor Changlian Zhu, Zhengzhou University
ClinicalTrials.gov Identifier: NCT00817401     History of Changes
Other Study ID Numbers: HN-200084001
Study First Received: January 2, 2009
Last Updated: January 5, 2009
Health Authority: China: Ministry of Health

Keywords provided by Zhengzhou University:
asphyxia
hypothermia
hypoxic-ischemic encephalopathy
neonates

Additional relevant MeSH terms:
Brain Ischemia
Hypothermia
Ischemia
Brain Damage, Chronic
Delirium
Encephalitis
Hepatic Encephalopathy
Neurotoxicity Syndromes
Hypoxia-Ischemia, Brain
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Body Temperature Changes
Signs and Symptoms
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013