RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-02-21

Study Completion:2026-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05547165

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Days to 32 Days

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	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. 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. 1. Parents or legal guardian do not speak English or Spanish

Inclusion Criteria

Exclusion 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

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.
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.
1. Parents or legal guardian do not speak English or Spanish

Contacts and Locations

Study Contact

Carl H Backes

CONTACT

16143556729

carl.backes@nationwidechildrens.org

Jonathan Slaughter

CONTACT

16143556643

jonathan.slaughter@nationwidechildrens.org

Study Locations (Sites)

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

Saint 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

Collaborators and Investigators

Sponsor: Nationwide Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-21

Study Completion Date2026-02-28

Study Record Updates

Study Start Date2023-02-21

Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Ductus Arteriosus, Patent