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

RecruitingPhase 2Ages any - 27 WeeksAllMount Sinai Hospital, Canada
NCT05340582 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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).
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What it tests

  • Acetaminophen Injection
  • Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen)
  • Sodium chloride 0.9% injection
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Where

9 sites
John Hunter Hospital
Newcastle, Australia
Royal North Shore Hospital
St Leonards, Australia
Royal Alexandra Hospital
Edmonton, Canada
McMaster Children's Hospital
Hamilton, Canada
Sunnybrook Health Sciences Centre
Toronto, Canada
Mount Sinai Hospital
Toronto, Canada
Centre Hospitalier de l'Université Laval
Québec, Canada
Prince of Wales Hospital
Shatin, Hong Kong

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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