Comparing two methods to treat a heart condition in premature infants
1/2 percutaneous intervention versus observational trial of arterial ductus in lower gestational age infants (PIVOTAL)
This study is looking at a new, less invasive way to fix a heart condition called patent ductus arteriosus (PDA) in preterm babies, to see if it works better than just waiting and watching, and it could help improve their health if they haven't responded to medication.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Research Inst Nationwide Children's Hosp NIH-funded |
| Lab location | 1 site (Columbus, United States) |
| Project ID | NIH-11021001 on NIH RePORTER |
What this research studies
This research investigates the effectiveness of a minimally invasive procedure called percutaneous catheter-based closure (PPC) for treating patent ductus arteriosus (PDA) in preterm infants, compared to a watchful waiting approach. PDA is a common heart condition in these infants that can lead to serious complications like chronic lung disease and brain injury. The study aims to determine if PPC can provide a safer and more effective closure option for infants who do not respond to medication. By enrolling in this research, patients may receive access to innovative treatment options that could improve their health outcomes.
Who could benefit from this research
Good fit: Ideal candidates for this research are premature infants diagnosed with symptomatic patent ductus arteriosus who have not responded to medication.
Not a fit: Patients who are not premature or those whose PDA has resolved spontaneously may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could lead to improved treatment options for premature infants with PDA, potentially reducing the risk of long-term complications.
How similar studies have performed: Previous research has shown promising results with similar minimally invasive techniques for other cardiovascular conditions in infants, suggesting potential for success in this approach.
Where this research is happening
Columbus, United States
- Research Inst Nationwide Children's Hosp — Columbus, United States (Active)
Researchers
- Principal investigator: Backes, Carl — Research Inst Nationwide Children's Hosp
- Study coordinator: Backes, Carl
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.