Safety of milrinone use in neonatal intensive care units

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

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background: Milrinone use in the neonatal intensive care unit has increased over the last 10. years despite a paucity of published safety data in infants. We sought to determine the safety of milrinone therapy among infants in the neonatal intensive care unit. Methods: We conducted a retrospective data analysis, identifying all infants who were exposed to milrinone and discharged from 322 neonatal intensive care units managed by the Pediatrix Medical Group from 1997-2010. We identified adverse events (AEs) during milrinone exposure. The unit of observation for clinical AEs was the first course of milrinone and for laboratory AEs it was an infant-day of exposure to milrinone. Results: Overall, 1446 of 716,821 (0.2%) infants received milrinone for a total of 6894 infant-days. The proportion of infants exposed to milrinone increased from 0 in 1997 to 4/1000 infant cases in 2010. Persistent pulmonary hypertension (40%) was the most commonly reported diagnosis at the start of milrinone administration. Overall, 606/1446 (42%) of infants had at least 1 clinical AE recorded during milrinone therapy. Hypotension requiring pressors and thrombocytopenia (<100,000/mm3) were the most commonly reported clinical and laboratory AEs, respectively. Death was reported in 8% of infants during the first course of milrinone therapy. Conclusion: Among infants hospitalized in the neonatal intensive care unit, there was an increase in the use of milrinone over the past 13. years. The safety, dosing, and efficacy of milrinone in infants should be determined in prospective clinical trials.

Original languageEnglish (US)
Pages (from-to)31-35
Number of pages5
JournalEarly Human Development
Volume91
Issue number1
DOIs
StatePublished - Jan 1 2015

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Milrinone
Neonatal Intensive Care Units
Safety
Pulmonary Hypertension
Thrombocytopenia
Hypotension

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health
  • Obstetrics and Gynecology

Cite this

on behalf of the Best Pharmaceuticals for Children Act-Pediatric Trials Network Administrative Core Committee (2015). Safety of milrinone use in neonatal intensive care units. Early Human Development, 91(1), 31-35. https://doi.org/10.1016/j.earlhumdev.2014.10.007
on behalf of the Best Pharmaceuticals for Children Act-Pediatric Trials Network Administrative Core Committee. / Safety of milrinone use in neonatal intensive care units. In: Early Human Development. 2015 ; Vol. 91, No. 1. pp. 31-35.
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title = "Safety of milrinone use in neonatal intensive care units",
abstract = "Background: Milrinone use in the neonatal intensive care unit has increased over the last 10. years despite a paucity of published safety data in infants. We sought to determine the safety of milrinone therapy among infants in the neonatal intensive care unit. Methods: We conducted a retrospective data analysis, identifying all infants who were exposed to milrinone and discharged from 322 neonatal intensive care units managed by the Pediatrix Medical Group from 1997-2010. We identified adverse events (AEs) during milrinone exposure. The unit of observation for clinical AEs was the first course of milrinone and for laboratory AEs it was an infant-day of exposure to milrinone. Results: Overall, 1446 of 716,821 (0.2{\%}) infants received milrinone for a total of 6894 infant-days. The proportion of infants exposed to milrinone increased from 0 in 1997 to 4/1000 infant cases in 2010. Persistent pulmonary hypertension (40{\%}) was the most commonly reported diagnosis at the start of milrinone administration. Overall, 606/1446 (42{\%}) of infants had at least 1 clinical AE recorded during milrinone therapy. Hypotension requiring pressors and thrombocytopenia (<100,000/mm3) were the most commonly reported clinical and laboratory AEs, respectively. Death was reported in 8{\%} of infants during the first course of milrinone therapy. Conclusion: Among infants hospitalized in the neonatal intensive care unit, there was an increase in the use of milrinone over the past 13. years. The safety, dosing, and efficacy of milrinone in infants should be determined in prospective clinical trials.",
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on behalf of the Best Pharmaceuticals for Children Act-Pediatric Trials Network Administrative Core Committee 2015, 'Safety of milrinone use in neonatal intensive care units', Early Human Development, vol. 91, no. 1, pp. 31-35. https://doi.org/10.1016/j.earlhumdev.2014.10.007

Safety of milrinone use in neonatal intensive care units. / on behalf of the Best Pharmaceuticals for Children Act-Pediatric Trials Network Administrative Core Committee.

In: Early Human Development, Vol. 91, No. 1, 01.01.2015, p. 31-35.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety of milrinone use in neonatal intensive care units

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

AU - Samiee-Zafarghandy, Samira

AU - Raman, Sudha R.

AU - van den Anker, John N.

AU - McHutchison, Kerstin

AU - Hornik, Christoph P.

AU - Clark, Reese H.

AU - Brian Smith, P.

AU - Benjamin, Daniel K.

AU - Berezny, Katherine

AU - Barrett, Jeffrey

AU - Capparelli, Edmund

AU - Cohen-Wolkowiez, Michael

AU - Kearns, Gregory L.

AU - Laughon, Matthew

AU - Muelenaer, Andre

AU - Michael O'Shea, T.

AU - Paul, Ian M.

AU - Wade, Kelly

AU - Walsh, Thomas J.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - Background: Milrinone use in the neonatal intensive care unit has increased over the last 10. years despite a paucity of published safety data in infants. We sought to determine the safety of milrinone therapy among infants in the neonatal intensive care unit. Methods: We conducted a retrospective data analysis, identifying all infants who were exposed to milrinone and discharged from 322 neonatal intensive care units managed by the Pediatrix Medical Group from 1997-2010. We identified adverse events (AEs) during milrinone exposure. The unit of observation for clinical AEs was the first course of milrinone and for laboratory AEs it was an infant-day of exposure to milrinone. Results: Overall, 1446 of 716,821 (0.2%) infants received milrinone for a total of 6894 infant-days. The proportion of infants exposed to milrinone increased from 0 in 1997 to 4/1000 infant cases in 2010. Persistent pulmonary hypertension (40%) was the most commonly reported diagnosis at the start of milrinone administration. Overall, 606/1446 (42%) of infants had at least 1 clinical AE recorded during milrinone therapy. Hypotension requiring pressors and thrombocytopenia (<100,000/mm3) were the most commonly reported clinical and laboratory AEs, respectively. Death was reported in 8% of infants during the first course of milrinone therapy. Conclusion: Among infants hospitalized in the neonatal intensive care unit, there was an increase in the use of milrinone over the past 13. years. The safety, dosing, and efficacy of milrinone in infants should be determined in prospective clinical trials.

AB - Background: Milrinone use in the neonatal intensive care unit has increased over the last 10. years despite a paucity of published safety data in infants. We sought to determine the safety of milrinone therapy among infants in the neonatal intensive care unit. Methods: We conducted a retrospective data analysis, identifying all infants who were exposed to milrinone and discharged from 322 neonatal intensive care units managed by the Pediatrix Medical Group from 1997-2010. We identified adverse events (AEs) during milrinone exposure. The unit of observation for clinical AEs was the first course of milrinone and for laboratory AEs it was an infant-day of exposure to milrinone. Results: Overall, 1446 of 716,821 (0.2%) infants received milrinone for a total of 6894 infant-days. The proportion of infants exposed to milrinone increased from 0 in 1997 to 4/1000 infant cases in 2010. Persistent pulmonary hypertension (40%) was the most commonly reported diagnosis at the start of milrinone administration. Overall, 606/1446 (42%) of infants had at least 1 clinical AE recorded during milrinone therapy. Hypotension requiring pressors and thrombocytopenia (<100,000/mm3) were the most commonly reported clinical and laboratory AEs, respectively. Death was reported in 8% of infants during the first course of milrinone therapy. Conclusion: Among infants hospitalized in the neonatal intensive care unit, there was an increase in the use of milrinone over the past 13. years. The safety, dosing, and efficacy of milrinone in infants should be determined in prospective clinical trials.

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on behalf of the Best Pharmaceuticals for Children Act-Pediatric Trials Network Administrative Core Committee. Safety of milrinone use in neonatal intensive care units. Early Human Development. 2015 Jan 1;91(1):31-35. https://doi.org/10.1016/j.earlhumdev.2014.10.007