Status:
RECRUITING
Precision Dosing of Oral Ibuprofen for PDA, A Pilot RCT
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
McMaster University
Hamilton Academic Health Sciences Organization
Conditions:
Patent Ductus Arteriosus
Preterm
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE2
Brief 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 ble...
Detailed Description
Study Design Overview: This clinical trial is a single-center, pilot, randomized, controlled, triple-blind study designed to evaluate the feasibility and effectiveness of model-informed precision dos...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT07143201
Start Date
July 4 2024
End Date
July 1 2027
Last Update
August 27 2025
Active Locations (1)
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1
McMaster Children's Hospital - Neonatal Intensive Care Unit
Hamilton, Ontario, Canada, L8N 3Z2