Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)

PHASE2CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

January 1, 2015

Primary Completion Date

June 30, 2018

Study Completion Date

June 30, 2018

Conditions
Retinopathy of Prematurity
Interventions
DRUG

Caffeine citrate

Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose)

DRUG

Ibuprofen

Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days

DRUG

Ketorolac

Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days

Trial Locations (1)

11203

SUNY Downstate Medical Center/University Hospital of Brooklyn, Brooklyn

All Listed Sponsors
collaborator

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

NIH

collaborator

Food and Drug Administration (FDA)

FED

lead

State University of New York - Downstate Medical Center

OTHER

NCT02344225 - Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study) | Biotech Hunter | Biotech Hunter