100
Participants
Start Date
January 10, 2022
Primary Completion Date
September 30, 2024
Study Completion Date
September 30, 2024
Ibuprofen
"Pharmacotherapy, when indicated (ie, for severe PDA on echocardiography, irrespective of clinical symptoms, or a moderate PDA on echocardiography with at least moderate clinical illness), will be provided in the form of ibuprofen as first line agent at a standard dosing of 10 mg/kg followed by 2 doses of 5mg/kg every 24 h. The route of administration may be intravenous or enteral, as determined by the treating team.~For treated infants, follow-up echocardiography will be conducted at the end of the 3-day course and second course of treatment will be initiated if they still fulfill study treatment criteria as mentioned above. If any treatment-eligible infant has a contraindication to ibuprofen, use of acetaminophen will be permitted as an alternative agent."
RECRUITING
OU College of Medicine, University of Oklahoma, Oklahoma City
TERMINATED
Sharp Mary Birch Hospital for Women & Newborns, San Diego
RECRUITING
Children's Hospital of Orange County, Orange
RECRUITING
Stollery Children's Hospital, Edmonton
RECRUITING
British Columbia Women's Hospital, Vancouver
WITHDRAWN
Mount Sinai Hospital, Toronto
WITHDRAWN
Sunnybrook Health Sciences Centre, Toronto
RECRUITING
Centre Hospitalier Universitaire de Quebec, Québec
RECRUITING
IWK Health Center, Halifax
Lead Sponsor
Collaborators (1)
BC Children's Hospital Research Institute
OTHER
CHU de Quebec-Universite Laval
OTHER
Sunnybrook Health Sciences Centre
OTHER
Mount Sinai Hospital, Canada
OTHER
Sharp Mary Birch Hospital for Women & Newborns
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Dalhousie Medical Research Foundation
UNKNOWN
Children's Hospital of Orange County, OC, California, United States
UNKNOWN
University of Alberta
OTHER
University of Oklahoma
OTHER
IWK Health Centre
OTHER