Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants (PIVOTAL)
Ductus Arteriosus, Patent
About this trial
This is an interventional treatment trial for Ductus Arteriosus, Patent focused on measuring PDA
Eligibility Criteria
Inclusion Criteria:
- EPIs born between 22-weeks+0 days (220/7 wks) and 27-weeks+6 days (276/7 wks) gestation, inclusive
- Admitted to a study NICU
- Birth weight ≥700-grams
- Mechanically ventilated at time of consent and randomization
- HSPDA ("PDA Score" ≥6) noted on echocardiogram (ECHO)
- 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
- 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;
- Congenital lung abnormalities, (e.g. restrictive lung disease);
- Pharyngeal or airway anomalies (tracheal stenosis, choanal atresia);
- Treatment for acute abdominal process (e.g., necrotizing enterocolitis);
- Infants with planned surgery;
- Active infection requiring treatment;
- Chromosomal defects (e.g., Trisomy 18);
- Neuromuscular disorders;
- 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)
- 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.
ECHO-based Exclusion Criteria
- 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;
- Evidence of cardiac thrombus that might interfere with device placement;
- PDA diameter larger than 4 mm at the narrowest portion (consistent with FDA-approved instructions for Piccolo™ device use).
- PDA length smaller than 3 mm (consistent with FDA-approved instructions for Piccolo™ device use).
- 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
Sites / Locations
- Arkansas Children's Hospital
- Children's Hospital Los Angeles
- Cedars-Sinai Medical Center
- Lucille Packard Children's Hospital at Stanford
- UC Davis Children's Hospital
- Children's Hospital Colorado
- Joe DiMaggio Children's Hospital
- Arnold Palmer Hospital for Children
- Ann and Robert H. Lurie Children's Hospital
- Boston Children's Hospital
- C.S. Mott Children's Hospital
- M Health Fairview University of Minnesota Masonic Children's Hospital
- St. Louis Children's Hospital
- Morgan Stanley Children's Hospital of New York-Presbyterian
- Cincinnati Children's Hospital Medical Center
- Nationwide Children's HospitalRecruiting
- Children's Hospital of Philadelphia
- Le Bonheur Children's Medical Center
- Monroe Carell Jr. Children's Hospital at Vanderbilt
- Medical City Children's Hospital
- UT Southwestern Children's Medical Center of Dallas
- Seattle Children's
- Children's Wisconsin
Arms of the Study
Arm 1
Arm 2
Active Comparator
Other
Primary Comparator
Secondary Intervention
Interventional groups that subject will be randomly assigned to include Percutaneous Patent Ductus Arteriosus Closure (PPC) or Responsive Management. Those assigned to PPC will undergo active intervention to close a hemodynamically significant patent ductus arteriosus (HSPDA) whereas those assigned to Responsive Management will be treated to manage the symptoms of the HSPDA and permit natural closure over time.
Sub-group of patients initially randomized to Responsive Management who may suffer a decline in health status that can be attributed to the presence of a hemodynamically significant patent ductus arteriosus (HSPDA). These patients, upon meeting pre-specified clinical criteria, will undergo active treatment via Percutaneous Patent Ductus Arteriosus Closure (PPC) as in the active comparator arm.