BridgeMD
New treatment option for Patent Ductus Arteriosus
Official title Precision Dosing of Oral Ibuprofen for PDA, A Pilot RCT
ClinicalTrials.gov ID: NCT07143201
What this study is testing
What is Standard Dose - Ibuprofen oral suspension?
Standard Dose - Ibuprofen oral suspension is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for patent ductus arteriosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 28
You may be able to join if
- 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...
- Obtained parental consent.
You likely can't join if
- 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
See the full eligibility 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 28 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.