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NCT Number: NCT00817401

Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy

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.

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Key information

Conditions

Hypoxic-Ischemic Encephalopathy Asphyxia Body Temperature Changes Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Death Hypothermia Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases Wounds and Injuries

Age range

1 hour–10 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

NICU, the Third Affiliated Hospital, Zhengzhou University

Zhengzhou, Henan, 450052, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestation age ≥37 weeks and body weight >2500g.
  • with one of the following factors:
  • Apgar score<5 at 5min;
  • Assisted respiration >3min due to respiratory distress;
  • pH≤7.1 of cord or arterial blood within 60min after birth;
  • clinical manifestation of encephalopathy during the first 10 hrs of life.

Exclusion criteria

  • Major congenital abnormalities;
  • Head trauma or skull fracture causing major intracranial hemorrhage;
  • Mild HIE;
  • Financial problems of the parents;
  • Lack of permanent address;
  • Postnatal age > 10 hrs

Treatment and study plan

Hypothermia

Device

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 names: TS Med 200, Germany

Primary outcomes

  1. Mortality and disability rate.

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Zhengzhou University

Other

Collaborators

  • Medical University Innsbruck

Registry information

Official study title

Effect of Systemic Hypothermia on Neonatal Hypoxic-Ischemic Encephalopathy

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Jan 6, 2009
Registry last updated
Jan 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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