Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage

PHASE3CompletedINTERVENTIONAL
Enrollment

610

Participants

Timeline

Start Date

February 28, 1993

Primary Completion Date

February 28, 1995

Study Completion Date

February 28, 1997

Conditions
Infant, NewbornInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, PrematureIntracranial Hemorrhages
Interventions
DRUG

Phenobarbital

10 mg of phenobarbital per kilogram of body weight intravenously over a period of 20 to 40 minutes (maximal dose, 1000 mg)

DRUG

Saline

Infusion of normal sal

Trial Locations (11)

20052

George Washington University, Washington D.C.

30303

Emory University, Atlanta

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

87131

University of New Mexico, Albuquerque

94304

Stanford University, Palo Alto

06504

Yale University, New Haven

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

NCT00009620 - Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage | Biotech Hunter | Biotech Hunter