NCT07143201 Precision Dosing of Oral Ibuprofen for PDA, A Pilot RCT
| NCT ID | NCT07143201 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hamilton Health Sciences Corporation |
| Condition | Patent Ductus Arteriosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2024-07-04 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 26 participants in total. It began in 2024-07-04 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 to give ibuprofen in a small number of newborns: 1 - standard amount of ibuprofen to everyone, which is the usual care or 2 - ibuprofen doses that will be changed based on how much active ibuprofen has reached the body and how well the newborn's PDA is closing. The investigators will then compare the number of PDAs closed in each group and closely monitor any possible challenges for this new practice. By doing this project, the goals can be summarized as below: A. Primary goal: To determine if it is feasible to successfully run a larger study in the future. B. Secondary goals 1. To assess how well and how safely the personalized (MIPD) method works, using a tool called WAPPS-PDA to guide dosing. 2. To compare the effectiveness and safety of the personalized method with standard ibuprofen dosing. 3. To identify drug levels in the blood (Cmin, AUC0-24, AUC0-72) that are associated with complete, partial, or no response to treatment.
Eligibility 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)
Contact & Investigator
Samira Samiee-Zafarghandy, MD, FRCPC
PRINCIPAL INVESTIGATOR
McMaster University
Frequently Asked Questions
Who can join the NCT07143201 clinical trial?
This trial is open to participants of all sexes, up to 28 Weeks, studying Patent Ductus Arteriosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07143201 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07143201 currently recruiting?
Yes, NCT07143201 is actively recruiting participants. Contact the research team at samiees@mcmaster.ca for enrollment information.
Where is the NCT07143201 trial being conducted?
This trial is being conducted at Hamilton, Canada.
Who is sponsoring the NCT07143201 clinical trial?
NCT07143201 is sponsored by Hamilton Health Sciences Corporation. The principal investigator is Samira Samiee-Zafarghandy, MD, FRCPC at McMaster University. The trial plans to enroll 26 participants.