Plain-English translation of NCT04898114 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 is testing whether nebulized combined with is more effective than alone for treating newborns with persistent pulmonary hypertension (a serious condition where blood pressure in the lungs stays dangerously high after birth). The study focuses on very sick newborns who are already on mechanical ventilation (breathing machines). Researchers believe that combining these two medications—one delivered as a mist the baby breathes in, and one given by mouth—may help more newborns recover.
Persistent pulmonary hypertension of newborns is life-threatening, and the most advanced treatments are often not available in many parts of the world. This trial explores whether combining these two more accessible medications could work as well as or better than expensive alternative treatments, giving more newborns a chance at survival.
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If your newborn is enrolled, you will remain in the hospital with your baby throughout the study. Your baby will receive either the combination treatment (nebulized plus sildenafil) or sildenafil alone (with a placebo mist), while continuing to receive all other needed medical care on the ventilator. The research team will monitor your baby's oxygen levels, heart function, and vital signs closely and collect information about how well the treatment works and any side effects.
AI-generated summary from trial data · Jun 16, 2026 · Not medical advice
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