40
Participants
Start Date
November 1, 2025
Primary Completion Date
September 1, 2027
Study Completion Date
September 1, 2027
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."
University of Rochester
OTHER