Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT

PHASE3RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

January 10, 2022

Primary Completion Date

September 30, 2024

Study Completion Date

September 30, 2024

Conditions
Patent Ductus Arteriosus After Premature Birth
Interventions
DRUG

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."

Trial Locations (9)

73117

RECRUITING

OU College of Medicine, University of Oklahoma, Oklahoma City

92123

TERMINATED

Sharp Mary Birch Hospital for Women & Newborns, San Diego

92868

RECRUITING

Children's Hospital of Orange County, Orange

Unknown

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WITHDRAWN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WITHDRAWN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

B3K 6R8

RECRUITING

IWK Health Center, Halifax

Sponsors
All Listed Sponsors
collaborator

BC Children's Hospital Research Institute

OTHER

collaborator

CHU de Quebec-Universite Laval

OTHER

collaborator

Sunnybrook Health Sciences Centre

OTHER

collaborator

Mount Sinai Hospital, Canada

OTHER

collaborator

Sharp Mary Birch Hospital for Women & Newborns

OTHER

collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

collaborator

Dalhousie Medical Research Foundation

UNKNOWN

collaborator

Children's Hospital of Orange County, OC, California, United States

UNKNOWN

collaborator

University of Alberta

OTHER

collaborator

University of Oklahoma

OTHER

lead

IWK Health Centre

OTHER