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.
N1 - Funding Information:
Dr. Smith receives salary support for research from the NIH , the U.S. Department of Health and Human Services , and the National Center for Advancing Translational Sciences of the NIH ( HHSN267200700051C , HHSN275201000003I , and UL1TR001117 ); he also receives research support from 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 , 5R01HD048689 , and 5R01HD060543 ). Dr. Hornik receives salary support for research from the National Center for Advancing Translational Sciences of the National Institutes of Health ( UL1TR001117 ). The remaining authors have no potential conflicts to disclose.
Funding Information:
This work was funded under NICHD contract HHSN27500016 for the Pediatric Trials Network. Research reported in this publication was also supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number UL1TR001117 . The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The sponsors played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the manuscript; or in the decision to submit the manuscript for publication.
Publisher Copyright:
© 2014 Elsevier Ltd.
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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U2 - 10.1016/j.earlhumdev.2014.10.007
DO - 10.1016/j.earlhumdev.2014.10.007
M3 - Article
C2 - 25460254
AN - SCOPUS:84921299603
VL - 91
SP - 31
EP - 35
JO - Screening
JF - Screening
SN - 0378-3782
IS - 1
ER -