NCT05617833View on ClinicalTrials.gov

Safety of Erythropoietin and Melatonin for Very Preterm Infants With Intraventricular Hemorrhage

PHASE1RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 30, 2024

Primary Completion Date

September 30, 2027

Study Completion Date

September 30, 2027

Conditions
Intraventricular Hemorrhage of Prematurity
Interventions
COMBINATION_PRODUCT

MLT+EPO

Melatonin component will be a daily dose of 30 mg/kg enteral administered in the evening in a split dose given at cares/feedings. EPO component is a two-stage regimen with high dose EPO (1000 U/kg/dose q 48 hrs ± 2hr subcutaneously or intravenously) for 10 doses followed by maintenance dose EPO (400 U/kg/dose q Monday, Wednesday, Friday subcutaneously or intravenously) to 33-6/7wk. Maintenance EPO dosing will begin on the day closest to completing the high dose series.

OTHER

Placebo

Placebo enteral and IV

Trial Locations (1)

21287

RECRUITING

Johns Hopkins Hospital, Baltimore

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Johns Hopkins University

OTHER