Caffeine Optimization for Oxygen Saturation Index in ELBW Infants

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

September 1, 2027

Study Completion Date

September 1, 2027

Conditions
Neonatal ApneaInfants
Interventions
DRUG

Caffeine Citrate

"High Dose Group:~Caffeine citrate administered as a 20 mg/kg loading dose followed by a 10 mg/kg/day maintenance dose starting at 7 days of life. Dose escalation up to 12.5 mg/kg/day may be performed based on clinical indications. The drug is administered either intravenously or orally in a blinded fashion.~Standard Dose Group:~Caffeine citrate administered as a 20 mg/kg loading dose followed by a 5 mg/kg/day maintenance dose starting at 7 days of life. Dose escalation up to 7.5 mg/kg/day may be performed based on clinical indications. The drug is administered either intravenously or orally in a blinded fashion."

All Listed Sponsors
lead

University of Rochester

OTHER