Whole-Body Cooling for Birth Asphyxia in Term Infants

PHASE3CompletedINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

October 31, 1999

Primary Completion Date

May 31, 2003

Study Completion Date

July 31, 2010

Conditions
Infant, NewbornHypoxia-Ischemia, Brain
Interventions
DEVICE

Induced hypothermia

Whole-body cooling using the Blanketrol II or III Units in the Automatic Control Mode with a YSI 400 series temperature probe placed in the distal esophagus over a 96-hour period

DEVICE

Control

Control group: standard care

Trial Locations (16)

27705

RTI International, Durham

30303

Emory University, Atlanta

33136

University of Miami, Miami

35233

University of Alabama at Birmingham, Birmingham

38163

University of Tennessee, Memphis

44106

Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland

45267

Cincinnati Children's Medical Center, Cincinnati

46202

Indiana University, Indianapolis

48201

Wayne State University, Detroit

75235

University of Texas Southwestern Medical Center at Dallas, Dallas

77030

University of Texas Health Science Center at Houston, Houston

87131

University of New Mexico, Albuquerque

94304

Stanford University, Palo Alto

06504

Yale University, New Haven

02138

Harvard University, Cambridge

02905

Brown University, Women & Infants Hospital of Rhode Island, Providence

All Listed Sponsors
collaborator

National Center for Research Resources (NCRR)

NIH

lead

NICHD Neonatal Research Network

NETWORK

NCT00005772 - Whole-Body Cooling for Birth Asphyxia in Term Infants | Biotech Hunter | Biotech Hunter