Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants (PIVOTAL)
Patent Ductus Arteriosus
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring catheter closure, conservative treatment, percutaneous closure
Eligibility Criteria
Maximum age (above) indicates qualifying / eligibility criteria. Participating infants will be followed until they reach 36 weeks corrected gestational age OR are discharged from the hospital, whichever comes first.
Inclusion Criteria:
- Preterm infants ≤28 weeks gestational age with hemodynamically-significant patent ductus arteriosus (PDA) at 2 - 4 weeks of age.
- Body weight greater than or equal to 700 grams
Exclusion Criteria:
- Significant genetic (ex.- Trisomy) or physiological (ex. - Omphalocele) abnormalities
- Other cardiac disease NOT INCLUDING atrial-septal defects or ventricular septal defects (ex. Tetrology of Fallot, Single ventricle physiology)
- Body weight less than 700 grams
Sites / Locations
- Nationwide Children's Hospital
- University of Tennessee Health Science Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Catheter-closure of PDA
Conservative management of PDA
Infants randomized to this group will undergo a catheter procedure to close hemodynamically-significant patent ductus arteriosus (HSPDA).
Infants randomized to this group will be treated to reduce the symptoms of a hemodynamically-significant patent ductus arteriosus (HSPDA), in the hopes that over time the HSPDA will become reduced in size (to the point of no longer meeting criteria for being "hemodynamically significant") or close naturally. Infants in this group with declining health status attributable to a PDA which meet qualifying criteria may receive catheter closure (intervention) if deemed medically necessary.