High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study

PHASE2TerminatedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Infant, PrematureErythropoietinBrain InjuryIntraventricular HemorrhagePeriventricular LeukomalaciaNeurodevelopmental OutcomesRandomized Clinical Trial
Interventions
DRUG

Erythropoietin

"5 of first 10 subjects (Group 1): 400 units/kg/dose once daily for 7 days 5 of next 10 subjects (Group 2): 800 units/kg/dose once daily for 7 days 20 of next 30 subjects (Group 3): 1000 units/kg/dose once daily for 7 days administered i.v. over 1 hour.~The volume of the study drug will be 1 mL in a 1 mL Tuberculin syringe to be administered over 1 hour."

DRUG

Saline placebo

Saline vehicle at a volume of 1 mL given over 1 hour intravenously once a day for the first seven days of life.

Trial Locations (1)

07960

Morristown Medical Center, Morristown

Sponsors
All Listed Sponsors
lead

Atlantic Health System

OTHER