Andrew Romaine1, Daniel Ye2, Zachary Ao3, Francia Fang4, Octavious Johnson5, Taylor Blake6, Daniel K Benjamin7, C Michael Cotten8, Daniela Testoni9, Reese H Clark10, Vivian H Chu11, P Brian Smith12, Christoph P Hornik13. 1. Duke Clinical Research Institute, Durham, NC, USA. Electronic address: aromaine@live.unc.edu. 2. Duke Clinical Research Institute, Durham, NC, USA. Electronic address: daniel.ye@duke.edu. 3. Duke Clinical Research Institute, Durham, NC, USA. Electronic address: aosterrr@gmail.com. 4. Duke Clinical Research Institute, Durham, NC, USA. Electronic address: francia.fang@duke.edu. 5. Duke Clinical Research Institute, Durham, NC, USA. Electronic address: octaviousjohnson33@yahoo.com. 6. Duke Clinical Research Institute, Durham, NC, USA. Electronic address: tsblake015@gmail.com. 7. Duke Clinical Research Institute, Durham, NC, USA. Electronic address: danny.benjamin@dm.duke.edu. 8. Duke Clinical Research Institute, Durham, NC, USA. Electronic address: michael.cotten@duke.edu. 9. Duke Clinical Research Institute, Durham, NC, USA. Electronic address: danielatestoni@gmail.com. 10. Pediatrix-Obstetrix Center for Research and Education, Sunrise, FL,USA. Electronic address: Reese_H_Clark@us.MEDNAX.com. 11. Duke Clinical Research Institute, Durham, NC, USA. Electronic address: vivian.chu@duke.edu. 12. Duke Clinical Research Institute, Durham, NC, USA. Electronic address: brian.smith@dm.duke.edu. 13. Duke Clinical Research Institute, Durham, NC, USA. Electronic address: christoph.hornik@dm.duke.edu.
Abstract
BACKGROUND: Histamine-2 receptor (H2) blockers are often used in very low birth weight infants despite lack of population specific efficacy and safety data. AIMS: We sought to describe safety and temporal trends in histamine-2 receptor (H2) blocker use in hospitalized very low birth weight (VLBW) infants. STUDY DESIGN: We conducted a retrospective cohort study using a clinical database populated by an electronic health record shared by 348 neonatal intensive care units in the United States. SUBJECTS: We included all VLBW infants without major congenital anomalies. OUTCOME MEASURES: We used multivariable logistic regression with generalizing estimating equations to evaluate the association between days of H2 blocker exposure and risk of: 1) death or necrotizing enterocolitis (NEC); 2) death or sepsis; and 3) death, NEC, or sepsis. RESULTS: Of 127,707 infants, 20,288 (16%) were exposed to H2 blockers for a total of 6,422,352days. Median gestational age for infants exposed to H2 blockers was 27weeks (25th 75th percentile 26, 29). H2 blocker use decreased from 18% of infants in 1997 to 8% in 2012 (p<0.001). On multivariable analysis, infants were at increased risk of the combined outcome of death, NEC, or sepsis on days exposed to H2 blockers (odds ratio=1.14) (95% confidence interval 1.08, 1.19). CONCLUSIONS: H2 blocker use is associated with increased risk of the combined outcome of death, NEC, or sepsis in hospitalized VLBW infants.
BACKGROUND: Histamine-2 receptor (H2) blockers are often used in very low birth weight infants despite lack of population specific efficacy and safety data. AIMS: We sought to describe safety and temporal trends in histamine-2 receptor (H2) blocker use in hospitalized very low birth weight (VLBW) infants. STUDY DESIGN: We conducted a retrospective cohort study using a clinical database populated by an electronic health record shared by 348 neonatal intensive care units in the United States. SUBJECTS: We included all VLBW infants without major congenital anomalies. OUTCOME MEASURES: We used multivariable logistic regression with generalizing estimating equations to evaluate the association between days of H2 blocker exposure and risk of: 1) death or necrotizing enterocolitis (NEC); 2) death or sepsis; and 3) death, NEC, or sepsis. RESULTS: Of 127,707 infants, 20,288 (16%) were exposed to H2 blockers for a total of 6,422,352days. Median gestational age for infants exposed to H2 blockers was 27weeks (25th 75th percentile 26, 29). H2 blocker use decreased from 18% of infants in 1997 to 8% in 2012 (p<0.001). On multivariable analysis, infants were at increased risk of the combined outcome of death, NEC, or sepsis on days exposed to H2 blockers (odds ratio=1.14) (95% confidence interval 1.08, 1.19). CONCLUSIONS: H2 blocker use is associated with increased risk of the combined outcome of death, NEC, or sepsis in hospitalized VLBW infants.
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