Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 31, 2002

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

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.

Trial Locations (1)

450052

NICU, the Third Affiliated Hospital, Zhengzhou University, Zhengzhou

All Listed Sponsors
collaborator

Medical University Innsbruck

OTHER

lead

Zhengzhou University

OTHER

NCT00817401 - Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy | Biotech Hunter | Biotech Hunter