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Multicenter Study
. 2016 Aug:99:27-30.
doi: 10.1016/j.earlhumdev.2016.05.010. Epub 2016 Jul 4.

Safety of histamine-2 receptor blockers in hospitalized VLBW infants

Andrew Romaine  1 , Daniel Ye  2 , Zachary Ao  3 , Francia Fang  4 , Octavious Johnson  5 , Taylor Blake  6 , Daniel K Benjamin Jr  7 , C Michael Cotten  8 , Daniela Testoni  9 , Reese H Clark  10 , Vivian H Chu  11 , P Brian Smith  12 , Christoph P Hornik  13 ; Best Pharmaceuticals for Children Act – Pediatric Trials Network
Affiliations
Multicenter Study

Safety of histamine-2 receptor blockers in hospitalized VLBW infants

Andrew Romaine et al. Early Hum Dev. 2016 Aug.

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.

Keywords: H2 blockers; Histamine-2 receptor antagonists; Infants; Necrotizing enterocolitis.

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Figures

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Figure 1
Temporal trend in H2 blocker use in very low birth weight infants
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