🏛️ Verified NIH Record • Updated 2026-03-31

Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants (NCT05340582)

Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants - The ACEDUCT Trial

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Mount Sinai Hospital, Canada

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (8 items).

Location: John Hunter Hospital — Newcastle, New South Wales

Age range: Not specified to 27 Weeks

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Chromosomal anomaly
  • Pre-treatment renal dysfunction defined as urine output \< 1ml/kg/hour for the previous 24 hours or serum creatinine \> 100 micromol/L
  • Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) \> 100 units/L94
  • Platelet count \<50,000 per microliter
  • Permission denied by the attending clinician to approach parents
  • Parental consent not available
  • Previous exposure to PDA medical treatment with any drug (prophylactic indomethacin use for prevention of intraventricular hemorrhage will not be considered as PDA treatment).

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (9 Sites)

  • John Hunter Hospital — Newcastle, New South Wales
  • Royal North Shore Hospital — St Leonards, New South Wales
  • Royal Alexandra Hospital — Edmonton, Ontario
  • McMaster Children's Hospital — Hamilton, Ontario
  • Sunnybrook Health Sciences Centre — Toronto, Ontario
  • Mount Sinai Hospital — Toronto, Ontario
  • Centre Hospitalier de l'Université Laval — Québec, Quebec
  • Prince of Wales Hospital — Shatin, NT
  • The Rotunda Hospital — Dublin,

📞 Contact the Study Coordinator

Phone: (416) 586-4800

Email: laura.thomas@sinaihealth.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Patent Ductus Arteriosus After Premature Birth clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗