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Co-administration of Acetaminophen with Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants – The ACEDUCT Trial
EU CTIS ID: 2023-503209-13-00
What this study is testing
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). Primary objective: To reduce the incidence of bronchopulmonary dysplasia or death in ELGANs receiving pharmacotherapy for PDA, by reducing treatment failure with the use of combination regime.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Preterm infants born <27+0 weeks gestational age admitted to one of four study NICUs: Mount Sinai Hospital, Sunnybrook Health Sciences Centre, McMaster Children’s Hospital, or the Rotunda Hospital
- 2. Permission given by the attending clinician to approach and then consent obtained from parents
- 3. Diagnosis of PDA ≥ 1.5 mm on echocardiography with unrestrictive predominantly left to right shunt
- 4. Designated to receive first treatment course with intravenous or enteral ibuprofen, as decided by the attending team.
You likely can't join if
- 1. Chromosomal anomaly
- 10. Cases of severe hepatocellular insufficiency.
- 2. Pre-treatment renal dysfunction defined as urine output < 1ml/kg/hour for the previous 24 hours or serum creatinine > 100 micromol/L
- 3. Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) > 100 units/L94
- 4. Platelet count <50,000 per microliter and no plan to transfuse platelets
- 5. Permission denied by the attending clinician to approach parents
See the full eligibility criteria
- 1. Preterm infants born <27+0 weeks gestational age admitted to one of four study NICUs: Mount Sinai Hospital, Sunnybrook Health Sciences Centre, McMaster Children’s Hospital, or the Rotunda Hospital
- 2. Permission given by the attending clinician to approach and then consent obtained from parents
- 3. Diagnosis of PDA ≥ 1.5 mm on echocardiography with unrestrictive predominantly left to right shunt
- 4. Designated to receive first treatment course with intravenous or enteral ibuprofen, as decided by the attending team.
- 1. Chromosomal anomaly
- 10. Cases of severe hepatocellular insufficiency.
- 2. Pre-treatment renal dysfunction defined as urine output < 1ml/kg/hour for the previous 24 hours or serum creatinine > 100 micromol/L
- 3. Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) > 100 units/L94
- 4. Platelet count <50,000 per microliter and no plan to transfuse platelets
- 5. Permission denied by the attending clinician to approach parents
- 6. Parental consent not available
- 7. Previous exposure to PDA medical treatment with any drug (prophylactic indomethacin use for prevention of intraventricular hemorrhage will not be considered as PDA treatment).
- 8. Use of any other investigational medicinal product within previous 30 days
- 9. Any other medical condition/or treatment that contraindicates treatment with paracetamol or ibuprofen, such ashypersensitivity to paracetamol, propacetamol hydrochloride, or to any of the excipients listed in Section 6.1 of the SmPC for Paracetamol 10mg/ml solution for infusion
The study team makes the final eligibility decision.
Where it's taking place
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.