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Safety of sildenafil in extremely premature infants: a phase I trial

Wesley Jackson1, Daniel Gonzalez2, P Brian Smith3,4

  • 1Department of Pediatrics, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. wesley.jackson@unc.edu.

Journal of Perinatology : Official Journal of the California Perinatal Association
|November 6, 2021
PubMed

Insights

Sildenafil is generally safe for premature infants. Careful administration is needed to prevent hypotension, especially with IV infusions.

Area of Science:

  • Neonatal pharmacology
  • Pediatric clinical trials

Background:

  • Premature infants may require interventions for various cardiorespiratory conditions.
  • Sildenafil's safety profile in this vulnerable population needs thorough investigation.

Purpose of the Study:

  • To assess the safety and tolerability of sildenafil in premature infants.
  • To identify potential adverse events associated with sildenafil administration.

Main Methods:

  • Phase I, open-label trial involving two cohorts of premature infants.
  • Cohort 1 received enteral sildenafil; Cohort 2 received single IV doses.
  • Safety assessed via adverse events, transaminase levels, and hemodynamic monitoring.

Main Results:

  • Sildenafil was well-tolerated in the study population.
  • One serious adverse event (hypotension) occurred in Cohort 2, linked to rapid IV infusion.
  • No adverse events related to elevated transaminases were observed.

Conclusions:

  • Sildenafil demonstrates a favorable safety profile in premature infants.
  • Attention to drug administration timing and infusion rates is crucial to mitigate risks like hypotension.
Abstract

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