Back to Trials
NCT05547165NARecruiting

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

Nationwide Children's Hospital

Start Date

2/21/2023

Completion Date

2/28/2026

Summary

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

DEVICE

Percutaneous Patent Ductus Arteriosus Closure (PPC)

COMBINATION_PRODUCT

Responsive Management Intervention

DIAGNOSTIC_TEST

Echocardiogram, cardiac

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Ductus Arteriosus, Patent

Locations

University of Alabama

Birmingham, Alabama 35294

United States

Arkansas Children's Hospital

Little Rock, Arkansas 72202

United States

Children's Hospital Los Angeles

Los Angeles, California 90027

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

Lucille Packard Children's Hospital at Stanford

Palo Alto, California 94304

United States

UC Davis Children's Hospital

Sacramento, California 95817

United States

Children's Hospital Colorado

Aurora, Colorado 80045

United States

Joe DiMaggio Children's Hospital

Hollywood, Florida 33021

United States

Orlando Health

Orlando, Florida 32806

United States

Ann and Robert H. Lurie Children's Hospital

Chicago, Illinois 60611

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

C.S. Mott Children's Hospital

Ann Arbor, Michigan 48109

United States

University of Minnesota, Masonic Children's Hospital

Minneapolis, Minnesota 55455

United States

St. Louis Children's Hospital

St Louis, Missouri 63110

United States

Morgan Stanley Children's Hospital of New York-Presbyterian

New York, New York 10032

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Le Bonheur Children's Medical Center

Memphis, Tennessee 38103

United States

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee 37232

United States

Medical City Children's Dallas

Dallas, Texas 75230

United States

UT Southwestern Children's Medical Center of Dallas

Dallas, Texas 75235

United States

Texas Children's

Houston, Texas 77030

United States

Seattle Children's

Seattle, Washington 98105

United States

Children's Wisconsin

Milwaukee, Wisconsin 53226

United States