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  • Original Article
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Sildenafil and retinopathy of prematurity risk in very low birth weight infants

Journal of Perinatology volume 36, pages 137–140 (2016)Cite this article

Subjects

Abstract

Objective:

To examine the effect of sildenafil therapy on development of severe retinopathy of prematurity (ROP) requiring surgical intervention in premature infants.

Study Design:

We identified premature infants who were discharged from Pediatrix Medical Group neonatal intensive care units from 2003 to 2012 and who received an ophthalmologic exam. We matched each infant exposed to sildenafil before first eye exam to three nonexposed infants using propensity scoring to control for differences in baseline infant characteristics. We evaluated the association between sildenafil exposure and development of severe ROP using conditional logistic regression.

Result:

Of the 57 815 infants meeting inclusion criteria, 88 were exposed to sildenafil. We matched 81/88 (92%) sildenafil-exposed with 243 nonexposed infants. There was no difference in the proportion of infants who developed severe ROP in the sildenafil-exposed vs nonexposed groups (17/81 (21%) vs 38/243 (16%), P=0.27). On adjusted analysis, there was no difference in severe ROP in the sildenafil-exposed vs nonexposed infants (odds ratio=1.46, 95% confidence interval=0.76 to 2.82, P=0.26).

Conclusion:

We did not observe an association between risk of severe ROP and sildenafil exposure before first eye exam in this cohort of premature infants.

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Acknowledgements

This work was performed under the Best Pharmaceuticals for Children Act – Pediatric Trials Network (Government Contract HHSN275201000003I).

Author information

Author notes

  1. S Samiee-Zafarghandy, J N van den Anker, M M Laughon, R H Clark, P B Smith and C P Hornik: The committee members are listed in the Supplementary Information.

Authors and Affiliations

  1. Center for Translational Science, Children’s National Medical Center, Washington, DC, USA

    S Samiee-Zafarghandy & J N van den Anker

  2. Division of Clinical Pharmacology, Children’s National Medical Center, Washington, DC, USA

    S Samiee-Zafarghandy & J N van den Anker

  3. Department of Pediatrics, McMaster University Medical Center, Hamilton, ON, Canada

    S Samiee-Zafarghandy

  4. Intensive Care, Erasmus Medical Center–Sophia Children’s Hospital, Rotterdam, The Netherlands

    J N van den Anker

  5. Department of Paediatric Pharmacology, University Children’s Hospital Basel, Basel, Switzerland

    J N van den Anker

  6. Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC, USA

    M M Laughon

  7. Pediatrix-Obstetrix Center for Research and Education, Sunrise, FL, USA

    R H Clark

  8. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA

    P B Smith & C P Hornik

  9. Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA

    P B Smith & C P Hornik

Authors
  1. S Samiee-Zafarghandy
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  2. J N van den Anker
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  3. M M Laughon
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  4. R H Clark
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  5. P B Smith
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  6. C P Hornik
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Consortia

on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Administrative Core Committee

Corresponding author

Correspondence to C P Hornik.

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Competing interests

Dr Smith receives salary support for research from the National Institutes of Health (NIH) and the National Center for Advancing Translational Sciences of the NIH (UL1TR001117), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (HHSN275201000003I and 1R01-HD081044-01) and the Food and Drug Administration (1R18-FD005292-01); he also receives research support from Cempra Pharmaceuticals (subaward to HHS0100201300009C) and industry for neonatal and pediatric drug development (www.dcri.duke.edu/research/coi.jsp). Dr van den Anker receives salary support for research from the NIH (5K24DA027992, 5U54HD071601, 5R01HD060543). Dr Hornik receives salary support for research from the National Center for Advancing Translational Sciences of the NIH (UL1TR001117). Dr Laughon receives support from the US government for his work in pediatric and neonatal clinical pharmacology (HHSN267200700051C, PI: Benjamin, under the Best Pharmaceuticals for Children Act) and from the NICHD (5K23HD068497-01). The other authors declare no conflict of interest.

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Supplementary Information accompanies the paper on the Journal of Perinatology website

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Samiee-Zafarghandy, S., van den Anker, J., Laughon, M. et al. Sildenafil and retinopathy of prematurity risk in very low birth weight infants. J Perinatol 36, 137–140 (2016). https://doi.org/10.1038/jp.2015.126

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