Treatment of heart murmur in premature babies using Ibuprofen
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
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 |
| Enrollment | 30 (estimated) |
| Ages | N/A to 29 Weeks |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 1 site (Ottawa) |
| Trial ID | NCT05325177 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants less than 29 weeks gestation who exhibit echocardiographic evidence of hsPDA requiring pharmacologic treatment.
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.
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 performed: Other studies have shown success with Ibuprofen in treating PDA, making this approach well-supported in existing literature.
Eligibility criteria
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 this trial is running
Ottawa
- The Ottawa General Hospital — Ottawa, Canada (Recruiting)
Study contacts
- Study coordinator: Nadya Ben Fadel, MD
- Email: nbenfadel@cheo.on.ca
- Phone: 613-737-7600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.