74
Participants
Start Date
June 30, 2006
Primary Completion Date
December 31, 2007
Study Completion Date
December 31, 2007
Inositol lower volume
60 mg/kg (1.2ml/kg) of myo-inositol 5% given intravenously over 20 minutes.
Inositol higher volume
120 mg/kg (2.4ml/kg) of myo-inositol 5% given intravenously over 20 minutes.
Placebo lower volume
60 mg/kg (1.2ml/kg) of glucose 5% given intravenously over 20 minutes.
Placebo higher volume
120 mg/kg (2.4ml/kg) of glucose 5% given intravenously over 20 minutes.
University of Rochester, Rochester
RTI International, Durham
Duke University, Durham
Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland
Indiana University, Indianapolis
Wayne State University, Detroit
University of Texas Southwestern Medical Center at Dallas, Dallas
University of Utah, Salt Lake City
University of New Mexico, Albuquerque
Yale University, New Haven
Brown University, Women & Infants Hospital of Rhode Island, Providence
National Eye Institute (NEI)
NIH
National Center for Research Resources (NCRR)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
NICHD Neonatal Research Network
NETWORK