Actively Recruiting
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants - The ACEDUCT Trial
Led by Mount Sinai Hospital, Canada · Updated on 2026-04-06
310
Participants Needed
9
Research Sites
12 weeks
Total Duration
On this page
Sponsors
M
Mount Sinai Hospital, Canada
Lead Sponsor
S
Sunnybrook Health Sciences Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the treatment of patent ductus arteriosus (PDA), a common heart complication in extremely premature infants born before 27 weeks gestation. The study aims to compare the effects, safety, and clinical outcomes of a combination therapy using ibuprofen plus intravenous acetaminophen versus ibuprofen alone, the current standard treatment. This Phase 2 trial also evaluates neurodevelopmental outcomes at 18 to 30 months corrected age to understand the long-term impact of the treatments. Participants will receive either standard ibuprofen dosing, given intravenously or enterally and adjusted by age, combined with intravenous acetaminophen administered every six hours for three days, or standard ibuprofen with a placebo saline injection on the same schedule. The dosing of ibuprofen typically involves a higher initial dose on day one, followed by lower daily doses on days two and three. The study is randomized and triple-blinded to compare these two groups effectively. During the trial, infants will be closely monitored for outcomes such as mortality before discharge, bronchopulmonary dysplasia severity, treatment success, kidney and liver function, and the need for further PDA treatment or procedures. Researchers will also track respiratory support duration, use of medications like diuretics and steroids, incidence of sepsis, and other complications up to 250 days after randomization. The trial spans from initial treatment through hospital discharge or transfer, with long-term neurodevelopmental assessments planned.
CONDITIONS
Brief Title
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infants born before 27+0 weeks gestational age
- Permission given by the attending clinician to approach and then consent obtained from parents
- Diagnosis of PDA 1.5 mm or larger on echocardiography with unrestrictive predominantly left to right shunt
- Designated to receive first treatment course with intravenous or enteral ibuprofen, as decided by the attending team
You will not qualify if you...
- Chromosomal anomaly
- Pre-treatment renal dysfunction defined as urine output less than 1 ml/kg/hour for the previous 24 hours or serum creatinine greater than 100 micromol/L
- Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) greater than 100 units/L
- Platelet count less than 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive intravenous or enteral ibuprofen as standard clinical care, along with either intravenous acetaminophen or placebo (0.9% saline) administered every 6 hours for 3 days.
Multiple medication administrations daily during hospitalization
Duration - Up to 250 days
Participants are monitored for outcomes such as mortality, bronchopulmonary dysplasia severity, and other health events until discharge or up to 250 days after randomization.
Regular assessments during hospital stay and follow-up visits up to 250 days
Trial Site Locations
Total: 9 locations
1
John Hunter Hospital
Newcastle, New South Wales, Australia, 2300
Active, Not Recruiting
2
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
3
Royal Alexandra Hospital
Edmonton, Ontario, Canada, T5H 3V9
Actively Recruiting
4
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
5
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
6
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Actively Recruiting
7
Centre Hospitalier de l'Université Laval
Québec, Quebec, Canada, G1V 4G2
Not Yet Recruiting
8
Prince of Wales Hospital
Shatin, NT, Hong Kong
Not Yet Recruiting
9
The Rotunda Hospital
Dublin, Ireland
Active, Not Recruiting
Research Team
L
Laura Thomas, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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