Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy

NCT00817401 | Completed Phase 1 DMC

• 1 other identifier: HN-200084001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic-Ischemic Encephalopathy

Keywords

asphyxia; hypothermia; hypoxic-ischemic encephalopathy; neonates

Outcome Measures

Primary Outcomes (1)

• Mortality and disability rate.

  18 months

Interventions

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.

Also known as: TS Med 200, Germany

Eligibility Criteria

• Age: 1 Hour - 10 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhengzhou University: lead
• Medical University Innsbruck: collaborator

Study Sites (1)

NICU, the Third Affiliated Hospital, Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Asphyxia; Hypothermia

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Death; Pathologic Processes; Wounds and Injuries; Body Temperature Changes

Study Officials

• Changlian Zhu, MD, PhD

  Zhengzhou University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 2, 2009
• First Posted: January 6, 2009
• Study Start: July 1, 2002
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: January 6, 2009

Record last verified: 2009-01

Locations

CN (1)