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

Eligibility Criteria

• 1. EPIs born between 22-weeks+0 days (220/7 wks) and 27-weeks+6 days (276/7 wks) gestation, inclusive
• 2. Admitted to a study NICU
• 3. Birth weight ≥700-grams
• 4. Mechanically ventilated at time of consent and randomization
• 5. HSPDA ("PDA Score" ≥6) noted on echocardiogram (ECHO)
• 6. Randomization is able to be performed within 5 days of the qualifying ECHO and when infant is 7-32 days postnatal
• 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)
• 10. Physician deems that the infant would not be a Percutaneous PDA Closure candidate due to clinical instability; however, if the infant's clinical status improves before 30-days postnatal and all inclusion criteria are still met, then the infant may be enrolled.
• 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).
• 5. PDA that does not meet inclusion requirements ("PDA Score" \<6).\* \* If a potential participant is found to have a PDA meeting eligibility requirements on a subsequent ECHO during the required period of 7 - 30 postnatal days of age, they may then be declared eligible to participate and enrolled, provided all other inclusion criteria are met and exclusion criteria are not met.
• 1. Parents or legal guardian do not speak English or Spanish