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Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy

NCT00817401 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-01-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medical University Innsbruck

    collaborator OTHER

  • Zhengzhou University

    lead OTHER

Principal Investigators

  • Changlian Zhu, MD, PhD · Zhengzhou University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
10 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2008-06-30
Completion
2008-06-30

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 NCT00817401 on ClinicalTrials.gov