Catheter closure versus watchful waiting for PDA in very small preterm babies
2/2 Percutaneous Intervention Versus Observational Trial of Arterial ductus management in Low-weight infants (PIVOTAL) Data Coordinating Center
['FUNDING_OTHER'] · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · NIH-11286626
This project compares a minimally invasive catheter procedure with careful monitoring to close a persistent patent ductus arteriosus in very low-weight preterm infants.
Quick facts
| Phase | ['FUNDING_OTHER'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | UNIVERSITY OF PITTSBURGH AT PITTSBURGH (nih funded) |
| Locations | 1 site (PITTSBURGH, UNITED STATES) |
| Trial ID | NIH-11286626 on ClinicalTrials.gov |
What this research studies
As a parent of a very small preterm baby with a persistent PDA after medicines didn't work, your baby may be treated with a tiny catheter device to close the duct or be closely watched with supportive care. Babies enrolled come from participating NICUs and will have medical data collected about breathing support, lung health, brain injury, and survival. A central data coordinating center at the University of Pittsburgh will manage enrollment, data quality, and analysis across sites. The aim is to find out whether earlier catheter closure reduces harm compared with waiting for the duct to close on its own.
Who could benefit from this research
Good fit: Ideal candidates are very low-weight preterm infants with a symptomatic, hemodynamically significant PDA that persists after the first postnatal week and after medications have failed to close it.
Not a fit: Babies whose PDA closes spontaneously, who respond to medication, or who are too medically unstable for a catheter procedure are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, earlier catheter closure could reduce the risk of chronic lung disease, brain injury, or death for some very low-weight preterm infants.
How similar studies have performed: Minimally invasive catheter closure is a newer option with promising early reports, but large randomized comparisons to watchful waiting are still limited.
Where this research is happening
PITTSBURGH, UNITED STATES
- UNIVERSITY OF PITTSBURGH AT PITTSBURGH — PITTSBURGH, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: WISNIEWSKI, STEPHEN R — UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- Study coordinator: WISNIEWSKI, STEPHEN R
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.
Conditions: Acquired brain injury