Condition: Patent Ductus Arteriosus After Premature Birth · Sponsor: Mount Sinai Hospital, Canada
Patent ductus arteriosus (PDA), the most common cardiovascular complication of prematurity, is associated with higher mortality and morbidities in extremely low gestational age neonates (ELGANs, \< 27+0 weeks). Ibuprofen and acetaminophen, which act by reducing prostaglandin synthesis, are the most commonly used first and second line agents for PDA treatment across Canada. However, initial treatment failure with monotherapy is a major problem, occurring in \>60% ELGANs. Treatment failure is associated with worsening rates of mortality and bronchopulmonary dysplasia (BPD), while early treatment success can achieve rates comparable to neonates without PDA. Treatment failure resulting in prolonged disease exposure is thought to be a major contributor. Recently, combination therapy with acetaminophen and ibuprofen has emerged as a new treatment regime. Acetaminophen exerts anti-prostaglandin effect through a different receptor site than ibuprofen, providing a biological rationale for their synergistic action. The objective of this study is to evaluate the clinical impact, efficacy and safety of combination regime (Ibuprofen + IV Acetaminophen) for the first treatment course for PDA in ELGANs vs. Ibuprofen alone (current standard treatment). The study will also evaluate the effects of combination regime vs. ibuprofen alone on neurodevelopmental outcomes at 18-30 months corrected age.
This description comes directly from the study's public registry record.
Laura Thomas, MSc · 416-586-4800 · laura.thomas@sinaihealth.ca
Always discuss trial participation with your own doctor first.
| John Hunter Hospital | Newcastle, New South Wales, Australia | Active Not Recruiting |
| Royal North Shore Hospital | St Leonards, New South Wales, Australia | Recruiting |
| Royal Alexandra Hospital | Edmonton, Ontario, Canada | Recruiting |
| McMaster Children's Hospital | Hamilton, Ontario, Canada | Recruiting |
| Sunnybrook Health Sciences Centre | Toronto, Ontario, Canada | Recruiting |
| Mount Sinai Hospital | Toronto, Ontario, Canada | Recruiting |
| Centre Hospitalier de l'Université Laval | Québec, Quebec, Canada | Not Yet Recruiting |
| Prince of Wales Hospital | Shatin, NT, Hong Kong | Not Yet Recruiting |
| The Rotunda Hospital | Dublin, Ireland | Active Not Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT05340582