Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy

PHASE3CompletedINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

May 31, 2002

Primary Completion Date

June 30, 2004

Study Completion Date

August 31, 2005

Conditions
Hypoxic-Ischemic Encephalopathy
Interventions
DEVICE

Cooling cap (YJW608-04B)

A semiconductor water circulation cooling device (YJW608-04B, Henyang Radio Manufactory, Hunan, China) was used to conduct head cooling. The hypothermia group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C. All infants were nursed under a servo-controlled radiant warmer and the rectal temperature was maintained at 34.5 to 35 degree C. Head cooling was started within 6 hours after birth for 72 hours followed by spontaneous re-warming and the average time to reach the target temperature was 2 hours.

Trial Locations (1)

201102

Children's Hospital, Fudan University, Shanghai

All Listed Sponsors
collaborator

Qingdao Children's Hospital

UNKNOWN

collaborator

Guangxi Maternity and Infant health Hospital

UNKNOWN

collaborator

Quanzhou Children's Hospital

OTHER

collaborator

The Second Hospital of Nanjing Medical University

OTHER

lead

Fudan University

OTHER

NCT00890409 - Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy | Biotech Hunter | Biotech Hunter