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

Trial ID or NCT#

NCT05547165

Status

not recruiting iconNOT RECRUITING

Purpose

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

Eligibility Criteria

Ages Eligible for Study: 7 Days to 32 Days
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. EPIs born between 22-weeks+0 days (220/7 wks) and 27-weeks+6 days (276/7 wks) gestation, inclusive2. Admitted to a study NICU3. Birth weight ≥700-grams4. Mechanically ventilated at time of consent and randomization5. 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:
  1. Clinical Exclusion Criteria
    1. 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.
  2. ECHO-based Exclusion Criteria
    1. 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.
  3. Other Exclusion Criteria
    1. 1. Parents or legal guardian do not speak English or Spanish

Investigator(s)

Susan R. Hintz, M.D., M.S. Epi.

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Contact

Lynn Peng, MD