RecruitingDuctus Arteriosus, Patent

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

Eligible age

0–0 yrs

Accepts

All genders

Locations

17 states

Healthy volunteers

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About this study

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.

Sponsor: Nationwide Children's Hospital

You may qualify if…

✓ 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

You may not qualify if…

✕ 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);