Plain-English translation of NCT07087782 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 Fortini, a specially formulated infant food that provides more calories in a smaller volume, helps babies with single-ventricle heart disease (a serious heart condition requiring surgery) grow better after their first operation. Babies with this condition often struggle to gain weight and have difficulty tolerating large feeding volumes. The study compares this medication to standard fortified infant formulas to see if it improves weight gain, feeding success, and reduces stress on families.
Babies with single-ventricle heart disease are at high risk during the period between their first and second heart surgeries, and poor weight gain during this time predicts serious complications. While this treatment is sometimes used in older children, no one has carefully studied whether it is safe and effective for very young babies with this condition, so this research aims to fill that gap.
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If your baby is enrolled, you will be randomly assigned to either receive Fortini formula or continue with standard fortified infant formula when your baby goes home from the hospital. You will feed your baby according to your assignment and keep track of feeding experiences, weight gain, and how manageable the feeding plan is for your family. You will attend follow-up appointments so the research team can measure your baby's growth and ask you about your feeding experience before your baby's next heart surgery.
AI-generated summary from trial data · Aug 26, 2026 · Not medical advice
United States