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Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00817401
Recruitment Status : Completed
First Posted : January 6, 2009
Last Update Posted : January 6, 2009
Medical University Innsbruck
Information provided by:
Zhengzhou University

Brief Summary:
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 or disease Intervention/treatment Phase
Hypoxic-Ischemic Encephalopathy Device: hypothermia Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Systemic Hypothermia on Neonatal Hypoxic-Ischemic Encephalopathy
Study Start Date : July 2002
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

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

Primary Outcome Measures :
  1. Mortality and disability rate. [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00817401

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China, Henan
NICU, the Third Affiliated Hospital, Zhengzhou University
Zhengzhou, Henan, China, 450052
Sponsors and Collaborators
Zhengzhou University
Medical University Innsbruck
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Study Director: Changlian Zhu, MD, PhD Zhengzhou University
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Responsible Party: Professor Changlian Zhu, Zhengzhou University Identifier: NCT00817401    
Other Study ID Numbers: HN-200084001
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: January 6, 2009
Last Verified: January 2009
Keywords provided by Zhengzhou University:
hypoxic-ischemic encephalopathy
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Body Temperature Changes
Signs and Symptoms, Respiratory
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain