Percutaneous Intervention Versus Observational Trial for Patent Ductus Arteriosus in Low Weight Infants
This study is looking at the best way to manage a condition called Patent Ductus Arteriosus (PDA) in premature infants. PDA is when a blood vessel in the heart that is normally open before birth doesn't close as it should after birth. Researchers are comparing two approaches: closing the PDA using a device called the Amplatzer Piccolo™ Occluder, or carefully watching the PDA and only treating it if certain problems arise. This study aims to see which approach leads to more days where infants don't need breathing support (ventilator-free days). You might be able to join if your baby is a premature infant (born between 22 and 27 weeks gestation), weighs at least 700 grams, is on a breathing machine, and has a specific PDA score on an echocardiogram (an ultrasound of the heart). The study plans to enroll 240 infants, but its current recruitment status is unclear.
- Study design
- This is an interventional study comparing two treatment approaches for PDA. It plans to enroll 240 participants.
- What's involved
- Infants in one group will have a catheter-based procedure to close the PDA within 48 hours of joining the study. Infants in the other group will be monitored, and treatment will only be given if specific health thresholds are met.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main outcome of the study is measured at 30 days after joining the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
At a glance
Conditions
NCT05547165
Where you'd take part
This study runs at 24 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinoisstudy coordinator listed
Recruiting
Arkansas Children's Hospital
Little Rock, Arkansasstudy coordinator listed
Recruiting
Boston Children's Hospital
Boston, Massachusettsstudy coordinator listed
Recruiting
Cedars-Sinai Medical Center
Los Angeles, Californiastudy coordinator listed
Recruiting
Children's Wisconsin
Milwaukee, Wisconsinstudy coordinator listed
Recruiting
Joe DiMaggio Children's Hospital
Hollywood, Floridastudy coordinator listed
Recruiting
Le Bonheur Children's Medical Center
Memphis, Tennesseestudy coordinator listed
Recruiting
Medical City Children's Dallas
Dallas, Texasstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Number of days free of ventilatory support requirement (ventilator-free days; VFDs)30 days post-randomization
Ventilator free days (VFDs) are defined as the number of days that a subject is alive and free from mechanical ventilatory support. VFDs are an established respiratory outcome measure in pediatric clinical trials, and are a strong predictor of short-term and longer-term oucomes, including length of neonatal intensive care unit (NICU) stay, morbidities, and mortality.