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 language | English (US) |
|---|---|
| Pages (from-to) | 31-35 |
| Number of pages | 5 |
| Journal | Early Human Development |
| Volume | 91 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jan 1 2015 |
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All Science Journal Classification (ASJC) codes
- Pediatrics, Perinatology, and Child Health
- Obstetrics and Gynecology
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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 journal › Article
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.
UR - http://www.scopus.com/inward/record.url?scp=84921299603&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84921299603&partnerID=8YFLogxK
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 - Early Human Development
JF - Early Human Development
SN - 0378-3782
IS - 1
ER -