Treatment of heart murmur in premature babies using Ibuprofen
Official title: A Pilot, Randomized Controlled Study of the Effects of High Dose Ibuprofen on Cerebral and Splanchnic Tissue Oxygenation During Treatment of Hemodynamically Significant Patent Ductus Arteriosus (hsPDA) in Preterm Infants
Run by Ottawa Hospital Research Institute · NCT05325177 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing whether different doses of Ibuprofen can help close a heart condition in premature babies born before 29 weeks and improve their health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 29 Weeks |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 1 site (Ottawa) |
| Trial ID | NCT05325177 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are preterm infants less than 29 weeks gestation who exhibit echocardiographic evidence of hsPDA requiring pharmacologic treatment.
✕Probably not a fit
Patients who may not benefit from this study include those with congenital heart disease, lethal genetic malformations, or contraindications to Ibuprofen therapy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of standard and high doses of Ibuprofen in treating patent ductus arteriosus (PDA) in preterm infants born before 29 weeks of gestation. The study involves monitoring the infants using echocardiograms to assess the presence of hsPDA and the subsequent response to Ibuprofen treatment. Additionally, near-infrared spectroscopy (NIRS) will be utilized to evaluate changes in tissue oxygenation during the treatment process. The goal is to determine the optimal dosing strategy for closing the PDA and improving outcomes for these vulnerable infants.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the health outcomes of premature infants by effectively closing PDA and reducing associated complications.
How similar studies have gone: Other studies have shown success with Ibuprofen in treating PDA, making this approach well-supported in existing literature.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterm infants less than (\< )29 weeks gestation at birth * Echocardiographic evidence of hsPDA (as outlined in the NICU PDA treatment guidelines) at 7-21 days of life requiring pharmacologic treatment as determined by the managing physician. Exclusion Criteria: * Not able to consent for any reason * Preterm infants with congenital heart disease except for PDA, PFO (patent foramen ovale), small and restrictive ASD (atrial septal defect), or small VSD (ventricular septal defect). * Preterm infants with lethal genetic malformations. * Preterm infants with congenital abdominal wall defects (omphalocele, gastroschisis). * Preterm infants with congenital or acquired brain anomaly. * Infants who receive ibuprofen for PDA treatment during the first week of life will be excluded. We will recruit infants between day 7 and 21 only because high-dose ibuprofen is not indicated during the first week of life * Preterm infants with contraindications to Ibuprofen therapy, including severe intraventricular hemorrhage (IVH), low platelet count \< 50,000 platelets per microliter, renal impairment with creatinine \>160 mmol/L or necrotizing enterocolitis (NEC) \> Stage 2 (using modified bell's Criteria). * Preterm infants with spontaneous intestinal perforation (SIP). * Acute kidney injury (defined as an increase in serum creatinine of 50% or more from the previous lowest value or a urinary output of less than 1 mL/kg per hr.).
Where it's running
-
The Ottawa General Hospital
Ottawa, Canada Recruiting
Study contacts
- Study coordinator: Nadya Ben Fadel, MD
- Email: nbenfadel@cheo.on.ca
- Phone: 613-737-7600
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Combining acetaminophen and ibuprofen to treat heart issues in premature infants
This study is testing if giving premature infants both acetaminophen and ibuprofen together can help treat a heart problem called patent ductus arteriosus better than using just one of the medicines alone.
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.