Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants

Exclusion Criteria

• •1. Life-threatening congenital defects (including congenital heart disease such as aortic coarctation or pulmonary artery stenosis). PDA and small atrial/ventricular septal defects are permitted;
• •2. Congenital lung abnormalities, (e.g. restrictive lung disease);
• •3. Pharyngeal or airway anomalies (tracheal stenosis, choanal atresia);
• •4. Treatment for acute abdominal process (e.g., necrotizing enterocolitis);
• •5. Infants with planned surgery;
• •6. Active infection requiring treatment;
• •7. Chromosomal defects (e.g., Trisomy 18);
• •8. Neuromuscular disorders;
• •9. Infants whose parents have chosen to allow natural death (do not resuscitate order) or for whom limitation of intensive care treatment is being considered (e.g. severe intraventricular hemorrhage)
• •1. Pulmonary hypertension (defined by ductal right to left shunting for \>33% of the cardiac cycle) in which early PDA closure may increase right ventricular afterload and compromise pulmonary and systemic blood flow;
• •2. Evidence of cardiac thrombus that might interfere with device placement;
• •3. PDA diameter larger than 4 mm at the narrowest portion (consistent with FDA-approved instructions for Piccolo™ device use).
• •4. PDA length smaller than 3 mm (consistent with FDA-approved instructions for Piccolo™ device use).
• •1\. Parents or legal guardian do not speak English or Spanish