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Precision Dosing of Oral Ibuprofen for PDA, A Pilot RCT

RecruitingPhase 2Ages any - 28 WeeksAllHamilton Health Sciences Corporation
NCT07143201 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Newborns born early are at risk for a serious health problem called patent ductus arteriosus (PDA). PDA is a passageway between heart and lung that can cause life-threatening complications such as bleeding in the brain or even death if it remains open and large. When closure of PDA is needed, doctors make every attempt to do it as soon as possible. Ibuprofen is the best drug to close the PDA, but it only works for 50% of small newborns. The investigators have shown before that small newborns handle ibuprofen differently and the amount of active ibuprofen that reaches their blood can be very unpredictable. Studies have shown if enough ibuprofen reaches the body, it can close the PDA. Therefore the investigators designed this study to see whether it is possible to give each newborn the right amount of ibuprofen that their body needs to close the PDA. The investigators will compare two ways

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📋 Eligibility rules (as published)
Inclusion Criteria: * Neonates with a gestational age of ≤27+6 weeks * Admitted to the neonatal intensive care unit (NICU) at McMaster Children's Hospital (MCH) * Diagnosed with PDA in need of treatment based on targeted neonatal echocardiography (TnEcho) performed prior to 27+6 CGA or postnatal age of 3 days, whichever comes later. * Obtained parental consent. Exclusion Criteria: * Major congenital or genetic abnormalities * Evidence for clinical or biochemical hepatic or renal failure (AST \> 225 U/L, ALT \> 150 U/L, or serum creatinine \> 130 µmol/L) * Sepsis - as defined by confirmed uncontrolled/active sepsis which will preclude any treatment of PDA * Contraindications to receive oral ibuprofen: * Severe hyperbilirubinemia in need for exchange transfusion * Severe feeding intolerance * Necrotizing enterocolitis (NEC) * Gastrointestinal perforation * Active bleeding * Severe thrombocytopenia (\< 50× 109/L)
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What it tests

  • Standard Dose - Ibuprofen oral suspension
  • Precision Dose - Ibuprofen oral suspension
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Where

1 site
McMaster Children's Hospital - Neonatal Intensive Care Unit
Hamilton, Canada
🤝 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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