Comparing two treatments for a heart condition in premature infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama
  Birmingham, Alabama, United States Recruiting
• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• UC Davis Children's Hospital
  Sacramento, California, United States Recruiting
• Joe DiMaggio Children's Hospital
  Hollywood, Florida, United States Recruiting
• Orlando Health
  Orlando, Florida, United States Recruiting

Study contacts

• Study coordinator: Carl H Backes
• Email: carl.backes@nationwidechildrens.org
• Phone: 16143556729

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• HeartR PDA Occluder: Long-Term Follow-Up in Indonesian Patients

  This study tests how the HeartR PDA Occluder performs and stays safe in real-world use for children and adults with patent ductus arteriosus in Indonesia.

  Recruiting Lifetech Scientific (Shenzhen) Co., Ltd. · Pekanbaru, Riau · NCT07646704

• Precision dosing of oral ibuprofen to close PDA in very preterm newborns

  This study will test whether adjusting oral ibuprofen doses for each very preterm baby using blood levels and echocardiograms helps close a patent ductus arteriosus more often than the standard fixed dose.

  Recruiting Phase 2 Hamilton Health Sciences Corporation · Hamilton, Ontario · NCT07143201

• New ultrasound technology for monitoring brain blood flow in sick newborns

  This study is testing a new ultrasound technology to see if it can help monitor blood flow in the brains of sick newborns and preterm infants.

  Recruiting St. Olavs Hospital · Trondheim · NCT06646250

• Evaluating the Occlutech PDA Occluder for Patent Ductus Arteriosus

  This study is testing if the Occlutech PDA Occluder is safe and effective for people with patent ductus arteriosus (PDA) after it has been implanted.

  Recruiting at 11 sites Occlutech International AB · Montreal and 14 other locations · NCT05264753

• PGE2 metabolite levels and development of significant patent ductus arteriosus in preterm infants

  This study will see if blood levels of a prostaglandin E2 metabolite predict which preterm babies (≤32 weeks) develop a hemodynamically significant patent ductus arteriosus.

  Recruiting Ain Shams University · Cairo, Abbasia · NCT07338370

• Combining acetaminophen and ibuprofen to treat heart issues in premature infants

  This study is testing if giving premature infants both acetaminophen and ibuprofen together can help treat a heart problem called patent ductus arteriosus better than using just one of the medicines alone.

  Recruiting at 6 sites Phase 2 Mount Sinai Hospital, Canada · Newcastle, New South Wales and 8 other locations · NCT05340582

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.