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

Not Recruiting

Trial ID: NCT05547165


Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward.

Official Title

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

Stanford Investigator(s)


Inclusion 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

Exclusion Criteria:

Clinical 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)

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

ECHO-based Exclusion Criteria

   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.

Other Exclusion Criteria

1. Parents or legal guardian do not speak English or Spanish


device: Percutaneous Patent Ductus Arteriosus Closure (PPC)

combination product: Responsive Management Intervention

diagnostic test: Echocardiogram, cardiac

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lynn Peng, MD