NCT05340582 Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
| NCT ID | NCT05340582 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mount Sinai Hospital, Canada |
| Condition | Patent Ductus Arteriosus After Premature Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 310 participants |
| Start Date | 2022-12-12 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 310 participants in total. It began in 2022-12-12 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Preterm infants born \<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 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. 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).
Frequently Asked Questions
Who can join the NCT05340582 clinical trial?
This trial is open to participants of all sexes, up to 27 Weeks, studying Patent Ductus Arteriosus After Premature Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05340582 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05340582 currently recruiting?
Yes, NCT05340582 is actively recruiting participants. Visit ClinicalTrials.gov or contact Mount Sinai Hospital, Canada to inquire about joining.
Where is the NCT05340582 trial being conducted?
This trial is being conducted at Newcastle, Australia, St Leonards, Australia, Edmonton, Canada, Hamilton, Canada and 1 additional location.
Who is sponsoring the NCT05340582 clinical trial?
NCT05340582 is sponsored by Mount Sinai Hospital, Canada. The trial plans to enroll 310 participants.