Plain-English translation of NCT05340582 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing whether combining acetaminophen with ibuprofen works better than ibuprofen alone to treat patent ductus arteriosus (PDA), a common heart condition in extremely premature babies born before 27 weeks of pregnancy. Currently, doctors use ibuprofen as the first treatment, but it fails to close the duct in more than half of the tiniest babies, leading to serious complications. Researchers believe that using both medications together may work better because they work through different pathways in the body.
Many extremely premature babies develop a persistent opening in their heart that doesn't close with standard treatment, which puts them at risk for serious breathing problems and other complications. This trial is exploring whether combining two medications could improve treatment success rates and protect these vulnerable infants from long-term harm.
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If your baby is enrolled, your baby will receive either the combination of both medications or ibuprofen alone (with a placebo saline solution) given through an IV over 3 days. Your baby's medical team will monitor your baby's heart closely with ultrasounds and blood tests to see how well the treatment is working. Researchers will also follow your baby's development and health for up to 30 months after birth to understand the long-term effects of the treatment.
AI-generated summary from trial data · Jul 7, 2026 · Not medical advice
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