310
Participants
Start Date
December 12, 2022
Primary Completion Date
January 31, 2027
Study Completion Date
April 30, 2027
Acetaminophen Injection
Acetaminophen injection solution 1000 mg/100 mL (10 mg/mL) latex-free plastic bag - dosage for this protocol is 15mg/kg/dose IV four times a day for 3 days
Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen)
Ibuprofen is not a study drug - standard of care in participating NICUs in the standard clinical dose for neonates (typically, for neonates \< 7 days old - 10 mg/kg/dose on day 1, 5 mg/kg/dose q24h on days 2 and 3; for neonates \> 7 days old - 20 mg/kg/dose on day 1, 10 mg/kg/dose q24h on days 2 and 3)
Sodium chloride 0.9% injection
Placebo- IV q6h for 3 days
ACTIVE_NOT_RECRUITING
Royal North Shore Hospital, St Leonards
ACTIVE_NOT_RECRUITING
John Hunter Hospital, Newcastle
NOT_YET_RECRUITING
Royal Alexandra Hospital, Edmonton
RECRUITING
McMaster Children's Hospital, Hamilton
RECRUITING
Sunnybrook Health Sciences Centre, Toronto
RECRUITING
Mount Sinai Hospital, Toronto
NOT_YET_RECRUITING
Centre Hospitalier de l'Université Laval, Québec
NOT_YET_RECRUITING
Prince of Wales Hospital, Shatin
RECRUITING
The Rotunda Hospital, Dublin
Sunnybrook Health Sciences Centre
OTHER
McMaster Children's Hospital
OTHER
The Rotunda Hospital
OTHER
John Hunter Hospital
OTHER_GOV
Royal Alexandra Hospital
OTHER
Centre Hospitalier de l'Universite Laval (CHUL)
UNKNOWN
Royal North Shore Hospital
OTHER
Prince of Wales Hospital, Shatin, Hong Kong
OTHER
Mount Sinai Hospital, Canada
OTHER