Relative Effectiveness and Safety of Pharmacotherapeutic Agents for Patent Ductus Arteriosus (PDA) in Preterm Infants: A National Comparative Effectiveness Research (CER) Project

Status: Completed
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

Methods: Participants: Extremely preterm infants (\<29 weeks gestational age) with an echocardiography confirmed PDA who will be treated according to attending team Interventions: 1. Standard dose ibuprofen \[10-5-5 regimen, i.e., 10mg/kg followed by 2 doses of 5mg/kg at 24h intervals\] 2. Adjustable dose ibuprofen \[10-5-5 regimen if treated within the first week. Higher doses of ibuprofen up to a 20-10-10 regimen if treated after the postnatal age cut-off for lower dose as per the local center policy\] 3. Intravenous indomethacin \[0.1-0.3mg/kg every 12-24h for a total of 3 doses\]. 4. Acetaminophen \[Oral/intravenous\] (15mg/kg every 6h) for 3-7 days Outcomes: Primary: Failure of primary pharmacotherapy (Need for further medical and/or surgical/interventional treatment following an initial course of pharmacotherapy). Secondary: (a) Receipt of 2nd course of pharmacotherapy; (b) Surgical/interventional PDA closure; (c) CLD (d) NEC (stage 2 or greater) (e) Severe IVH (Grade III-IV) (f) Definite sepsis (g) Stage 1 or greater AKI; (h) Post-treatment serum bilirubin; (i) Phototherapy duration; (j) All-cause mortality during hospital stay.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 2 months
Healthy Volunteers: f
View:

• Extremely preterm infants (\<29 weeks gestational age) with an echocardiography confirmed PDA who will be treated according to attending team

Locations
Other Locations
Canada
Foothills Medical Centre
Calgary
Royal Alexandra Hospital
Edmonton
IWK Health Center
Halifax
Kingston Health Sciences Centre
Kingston
London Health Sciences Centre
London
The Moncton Hospital
Moncton
CHU Sainte-Justine
Montreal
Royal Columbian Hospital
New Westminster
Children's Hospital of Eastern Ontario
Ottawa
Centre Hospitalier Universitaire de Quebec
Québec
Regina General Hospital
Regina
Saint John Regional Hospital
Saint John
Royal University Hospital
Saskatoon
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke
Hospital for Sick Children
Toronto
Mount Sinai Hospital
Toronto
Sunnybrook Health Sciences Centre
Toronto
British Columbia Women's Hospital
Vancouver
Victoria General Hospital
Victoria
Windsor Regional Hospital
Windsor
Health Sciences Centre
Winnipeg
St. Boniface General Hospital
Winnipeg
Time Frame
Start Date: 2020-01-01
Completion Date: 2023-12-31
Participants
Target number of participants: 1663
Treatments
Indomethacin Arm
Intravenous indomethacin at 0.1-0.3 mg/kg IV every 12-24h for a total of 3 doses as choice of initial pharmacotherapy.
Standard dose ibuprofen Arm
Standard dose ibuprofen \[Oral/intravenous\] at 10 mg/kg followed by 2 doses of 5mg/kg at 24 h intervals irrespective of postnatal age as choice of initial pharmacotherapy.
Adjustable dose ibuprofen Arm
Adjustable dose ibuprofen \[Oral/intravenous\] as choice of initial pharmacotherapy. The dose of ibuprofen will be 10 mg/kg followed by 2 doses of 5 mg/kg at 24 h intervals if treated within the first 7 days after birth. Higher doses of ibuprofen up to 20 mg/kg followed by 2 doses of 10 mg/kg at 24 h intervals if treated after the postnatal age cut-off for lower dose as per the local center policy
Acetaminophen Arm
Acetaminophen \[Oral/intravenous\] at 15mg/kg every 6h for 3-7 days as choice of initial pharmacotherapy.
Control group
Infants \<29 weeks GA with echocardiography-confirmed PDA but never received any pharmacotherapy
Reference group
Infants \<29 weeks GA who were never diagnosed with PDA
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Windsor Regional Hospital, St. Boniface Hospital, Foothills Medical Centre, Royal Columbian Hospital Foundation, CHU de Quebec-Universite Laval, Victoria General Hospital, Regina General Hospital, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Sunnybrook Health Sciences Centre, MOUNT SINAI HOSPITAL, Royal University Hospital Foundation, Provincial Health Services Authority British Columbia, Horizon Health Network, The Moncton Hospital, Queen's University, Royal Alexandra Hospital, Health Sciences Centre, Winnipeg, Manitoba, St. Justine's Hospital, Children's Hospital of Eastern Ontario, London Health Sciences Centre, The Hospital for Sick Children
Leads: IWK Health Centre

This content was sourced from clinicaltrials.gov