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Comparing two treatments for a heart condition in premature infants

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

Not applicable Interventional Nationwide Children's Hospital · NCT05547165

This study is testing if a special device can help premature infants with a heart condition do better than just using medication.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment240 (estimated)
Ages7 Days to 32 Days
SexAll
SponsorNationwide Children's Hospital Academic / other
Locations24 sites (Birmingham, Alabama and 23 other locations)
Trial IDNCT05547165 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of percutaneous closure of the patent ductus arteriosus (PDA) using the PICCOLO device compared to supportive management in low-weight infants. The study aims to determine if the device closure leads to better outcomes than traditional medication management. Eligible participants include infants born between 22 and 27 weeks of gestation who are mechanically ventilated and have a significant PDA score. The trial will randomize participants within five days of qualifying echocardiograms to assess the best treatment approach.

Who should consider this trial

Good fit: Ideal candidates are infants born between 22 and 27 weeks of gestation, weighing at least 700 grams, and requiring mechanical ventilation.

Not a fit: Patients with life-threatening congenital defects or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could establish a new standard of care for treating patent ductus arteriosus in low-weight infants.

How similar studies have performed: While this approach has not been previously tested in randomized controlled trials, it builds on existing knowledge of PDA management.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 enrolled.

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

Where this trial is running

Birmingham, Alabama and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ductus Arteriosus, PatentPDA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.