Plain-English translation of NCT05547165 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing whether closing a heart opening in very premature babies using a small FDA-approved device called PICCOLO works better than treating symptoms while waiting for the opening to close naturally. The opening, called a patent ductus arteriosus, is normal before birth but should close after delivery; when it stays open in premature infants, it can cause serious problems. Researchers want to find out which approach — active closure with the device or supportive management — gives babies the best outcomes.
Currently, doctors treat this heart condition in different ways, but no large studies have proven which approach is truly better. This trial exists to provide clear evidence so that doctors can offer premature babies the most effective treatment.
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If your baby is enrolled, they will be randomly assigned to one of two groups: one group will receive the minimally invasive device procedure to close the heart opening, while the other group will receive supportive care with medications and close monitoring to manage symptoms and allow natural closure. Babies in the supportive care group who develop worsening symptoms related to the opening may later receive the device procedure if needed. Throughout the trial, your baby will have regular heart ultrasounds and clinical assessments to monitor progress.
AI-generated summary from trial data · Jul 4, 2026 · Not medical advice
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