Trial comparing treatments for Ductus Arteriosus, Patent
Official title Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
ClinicalTrials.gov ID: NCT05547165
What this study is testing
What is Responsive Management Intervention?
An investigational approach being studied for the treatment of patent ductus arteriosus (PDA) in infants.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares two ways to treat a common heart opening that stays open after birth in preterm infants. It wants to see if the device is better than medication.
- Who it's for
- It looks for very small, low‑weight newborns who have a heart opening that has not closed after birth.
- What's involved
- Participants may receive the PICCOLO device or supportive medication. They will have regular check‑ups and heart tests to monitor the opening.
- Time commitment
- The study lasts about a year, with several hospital visits for treatment, follow‑up exams, and heart monitoring.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 32
You may be able to join if
- EPIs born between 22-weeks+0 days (220/7 wks) and 27-weeks+6 days (276/7 wks) gestation, inclusive
- Admitted to a study NICU
- Birth weight ≥700-grams
- Mechanically ventilated at time of consent and randomization
- HSPDA ("PDA Score" ≥6) noted on echocardiogram (ECHO)
You likely can't join if
- Clinical Exclusion Criteria
- Life-threatening congenital defects (including congenital heart disease such as aortic coarctation or pulmonary artery stenosis).
- Congenital lung abnormalities, (e.g. restrictive lung disease);
- Pharyngeal or airway anomalies (tracheal stenosis, choanal atresia);
- Treatment for acute abdominal process (e.g., necrotizing enterocolitis);
- Infants with planned surgery;
See the full eligibility criteria
- EPIs born between 22-weeks+0 days (220/7 wks) and 27-weeks+6 days (276/7 wks) gestation, inclusive
- Admitted to a study NICU
- Birth weight ≥700-grams
- Mechanically ventilated at time of consent and randomization
- HSPDA ("PDA Score" ≥6) noted on echocardiogram (ECHO)
- Randomization is able to be performed within 5 days of the qualifying ECHO and when infant is 7-32 days postnatal
- Clinical Exclusion Criteria
- 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;
- Congenital lung abnormalities, (e.g. restrictive lung disease);
- Pharyngeal or airway anomalies (tracheal stenosis, choanal atresia);
- Treatment for acute abdominal process (e.g., necrotizing enterocolitis);
- Infants with planned surgery;
- Active infection requiring treatment;
- Chromosomal defects (e.g., Trisomy 18);
- Neuromuscular disorders;
- 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)
- Physician deems that the infant would not be a Percutaneous PDA Closure candidate due to clinical instability
- 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;
- Evidence of cardiac thrombus that might interfere with device placement;
- PDA diameter larger than 4 mm at the narrowest portion (consistent with FDA-approved instructions for Piccolo™ device use).
- PDA length smaller than 3 mm (consistent with FDA-approved instructions for Piccolo™ device use).
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Hollywood, Florida, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Columbus, Ohio, United States
- Memphis, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 days to 32 days. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Sacramento, California, United States; Hollywood, Florida, United States; Orlando, Florida, United States and 9 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.