Plain-English translation of NCT06613477 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.
This trial studied how digoxin, a heart medication, worked in newborn infants with single ventricle heart disease after their first surgical repair. Researchers tracked how the infant's body processed this medication and how well it helped their heart function. The goal was to figure out the best way to dose this treatment for babies of different sizes and ages.
Newborns with single ventricle heart disease need medication to help their heart work better between surgeries, but doctors weren't sure exactly how much medication was safe and effective for infants at this stage. This trial aimed to find the right dosing approach based on each baby's individual body characteristics.
Your baby would receive the heart medication by mouth every 12 hours, with the dose carefully calculated based on their weight, age, and kidney function. Over up to 180 days, your baby would have blood samples drawn at specific times to measure how their body was processing the medication and how well their heart was responding. You would have clinic visits for these blood draws and heart assessments, with your medical team monitoring your baby closely for any side effects or changes in heart function.
AI-generated summary from trial data · Aug 18, 2026 · Not medical advice
United States