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Safety of Sildenafil in Premature Infants With Severe Bronchopulmonary Dysplasia

Study on sildenafil's safety for premature infants with lung issues.

Recruiting
29 years and younger
All
Phase 2
  • Simplified description (AI rewritten)
  • Technical description (Original)

Sildenafil is a medicine usually used for heart and blood problems. This study tests its safety for very small babies with breathing problems called severe bronchopulmonary dysplasia (BPD). The study takes place in hospitals with special baby care units, called Neonatal Intensive Care Units (NICUs). Babies who are born too early and have severe BPD can join if they meet certain conditions. The study has different parts: Screening, Treatment, Weaning, Follow-up, and Final Assessment. During these parts, doctors will check the babies' health, medicine doses, breathing, and heart using tests like echocardiograms (pictures of the heart). Babies will be given either sildenafil or a fake medicine (placebo) for up to 28 days. The study checks the safety by watching for side effects. Parents must agree for their baby to join and cannot have been in the study before. Babies with serious heart issues or certain medical conditions cannot join.

  • The study lasts up to 28 days with several checks and medicine doses.
  • Parents must agree for their baby to join the study.
  • Babies with certain heart or medical issues cannot join.
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Study details
    Bronchopulmonary Dysplasia of Newborn

NCT04447989

Christoph Hornik

13 December 2024

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