Precision Dosing of Oral Ibuprofen for PDA, A Pilot RCT
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
| Condition(s) | Patent Ductus Arteriosus, Preterm |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | 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 |
| Ages | 28 Weeks |
| Sex | All |
| Lead sponsor | Hamilton Health Sciences Corporation |
| Locations | Hamilton, Ontario, Canada |
| Start date | 2024-07-04 |
| NCT ID | NCT07143201 |
| Official listing | https://clinicaltrials.gov/study/NCT07143201 |