Catheter closure versus watchful waiting for an open heart–lung blood vessel (patent ductus arteriosus) in very premature babies
1/2 percutaneous intervention versus observational trial of arterial ductus in lower gestational age infants (PIVOTAL)
This compares a minimally invasive catheter procedure to careful watchful waiting to close a persistent patent ductus arteriosus in very premature newborns.
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-11286636 on NIH RePORTER |
What this research studies
If your baby was born very early and the blood vessel between the heart and lungs (the ductus arteriosus) stays open after medicines, this research compares closing it with a thin catheter and device versus continuing observation. The trial focuses on infants with symptomatic, hemodynamically significant PDA after the first postnatal week when medications have not worked. Doctors will look at outcomes tied to lung and brain health and survival to see whether earlier catheter closure shortens harmful exposure to the PDA. The procedure studied is less invasive than traditional surgery and uses a small occluder device placed through a catheter.
Who could benefit from this research
Good fit: Ideal candidates are very preterm infants who still have a symptomatic, hemodynamically significant patent ductus arteriosus after the first week of life and after pharmacologic treatment has failed.
Not a fit: Babies whose ductus closes on its own, who respond to medication, or who are too medically unstable for a catheter procedure are unlikely to benefit from the catheter approach.
Why it matters
Potential benefit: If successful, timely catheter closure could reduce the risk of chronic lung disease, brain injury, or death and may avoid more invasive surgery.
How similar studies have performed: Catheter-based closure in preterm infants is a newer, less-invasive option with encouraging early reports but not yet proven by large randomized trials.
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.