170
Participants
Start Date
January 18, 2019
Primary Completion Date
June 1, 2023
Study Completion Date
June 1, 2023
Caffeine
Infants will be started on oral caffeine base at 5 mg/kg/day. At 36 weeks + 0 days PMA drug dose will be increased to 5 mg/kg BID (total daily dose 10 mg/kg). Dose will be weight-adjusted weekly until NICU (neonatal intensive care unit) discharge. After discharge, all new doses will be calculated from the last weight recorded prior to discharge. The research pharmacy will prepare a bulk oral solution with active drug (caffeine base). While in the hospital, a daily 24-hour supply will be prepared and dispensed. For home administration of study drug, the research pharmacy at each clinical site will prepare and dispense a sufficient quantity of caffeine base solution for outpatient treatment up to 42 weeks + 6 days.
Placebos
SyrSpend SF Unflavored will be used as the placebo for the control group infants. The volume of the placebo will match the volume of the study drug.
Children's Hospital of Philadelphia, Philadelphia
Children's National Medical Center/Children's Research Institute, Washington D.C.
Walter Reed National Military Medical Center, Bethesda
Johns Hopkins Bayview Medical Center, Baltimore
Johns Hopkins, Baltimore
AdventHealth Orlando, Orlando
Johns Hopkins All Children's Hospital, St. Petersburg
University of Mississippi, Jackson
University of Kentucky, Lexington
Cleveland Clinic, Cleveland
Loma Linda University Health System, Loma Linda
Kapiolani Medical Center, Honolulu
Beth Israel Deaconess Medical Center, Boston
University of Massachusetss, Worcester
Dartmouth Hitchcock Medical Center, Lebanon
Lead Sponsor
Boston University
OTHER
Beth Israel Medical Center
OTHER
University of Massachusetts, Worcester
OTHER
American SIDS Institute
OTHER
Walter Reed National Military Medical Center
FED
Dartmouth-Hitchcock Medical Center
OTHER
Children's Hospital of Philadelphia
OTHER
Johns Hopkins All Children's Hospital
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Children's National Research Institute
OTHER