Precision dosing of oral ibuprofen to close PDA in very preterm newborns
Official title: Model Informed Precision Dosing of Oral Ibuprofen for Treatment of Persistent Patent Ductus Arteriosus: A Pilot Randomized Controlled Feasibility Trial
Run by Hamilton Health Sciences Corporation · NCT07143201 · Data updated 2026-11-12
This study will test whether adjusting oral ibuprofen doses for each very preterm baby using blood levels and echocardiograms helps close a patent ductus arteriosus more often than the standard fixed dose.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 28 Weeks |
| Sex | All |
| Enrollment | 26 (estimated) |
| Sponsor | Hamilton Health Sciences Corporation Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Status | Recruiting |
| Started | July 4, 2024 |
| Main results expected | July 2026 |
| Study ends | July 2027 |
| Registry record updated | August 27, 2025 |
| Trial ID | NCT07143201 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Very preterm neonates (gestational age ≤27+6 weeks) admitted to the McMaster Children's Hospital NICU with a PDA judged to need treatment and with parental consent.
✕Probably not a fit
Infants with major congenital or genetic abnormalities, active uncontrolled sepsis, significant hepatic or renal failure, or contraindications to oral ibuprofen (for example NEC, GI perforation, severe thrombocytopenia, severe feeding intolerance, or hyperbilirubinemia requiring exchange transfusion) are unlikely to benefit and are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, pilot, randomized, controlled, triple-blind Phase 2 trial compares standard fixed oral ibuprofen dosing to model-informed precision dosing (MIPD) in preterm neonates ≤27+6 weeks with PDA. The MIPD arm uses initial loading doses followed by dose adjustments guided in real time by blood samples taken at 6, 30, and 54 hours and targeted echocardiography interpreted through the WAPPS-PDA Bayesian PK tool. The standard arm receives the same initial regimen but subsequent doses are not altered based on PK or echo results, although samples and echos are collected for comparison. The study focuses on feasibility, achieved drug exposure, and clinical PDA closure outcomes in a small cohort.
Why it matters
Potential benefit: If successful, personalized dosing could increase the chance of closing the PDA in very preterm infants and reduce complications from a persistent PDA.
How similar studies have gone: Prior work shows that adequate ibuprofen exposure is linked to PDA closure and that neonates have variable ibuprofen pharmacokinetics, but real-time model-informed precision dosing for PDA is relatively novel and not yet validated in larger trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
McMaster Children's Hospital - Neonatal Intensive Care Unit
Hamilton, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Samira Samiee-Zafarghandy, MD, FRCPC — McMaster University
- Study coordinator: Samira Samiee-Zafarghandy, MD, FRCPC
- Email: samiees@mcmaster.ca
- Phone: 1-905-521-2100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.