Association between caffeine citrate exposure and necrotizing enterocolitis in preterm infants

Lampkin, Stacie; Turner, Ann; Lakshminrusimha, Satyanarayana; Mathew, Bobby; Brown, Jack; Fominaya, Cory E; Johnson, Kristin K.

doi:10.2146/ajhp120457

Cited by 14 publications

(15 citation statements)

References 18 publications

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“…Data reported by the German Neonatal Network suggest that surgical procedures for NEC are more likely in infants receiving caffeine citrate (3 vs. 1.3%), but the gestational age in these two groups differed by as much as 2 weeks (mean gestational age in the caffeine group: 28.4 weeks, without caffeine: 30.5 weeks; W. Goepel, personal communication, May 2013). In a recent case-control study, no increased risk of NEC was observed in infants receiving caffeine citrate [13]. Our study shows that NEC was less likely with LP than with ECC, but this result has to be viewed with caution as this was not a randomized controlled trial and we cannot rule out that other changes in management had occurred contributing to a fall in the NEC rate.…”

Section: Discussioncontrasting

confidence: 56%

Safety Profile Comparison between Extemporaneous and a Licensed Preparation of Caffeine Citrate in Preterm Infants with Apnea of Prematurity

Vatlach¹,

Arand²,

Engel

et al. 2013

Neonatology

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Background: Given the lack of a licensed product (LP), extemporaneous caffeine citrate (ECC) has been used by many hospital pharmacies. Objectives: Since July 2011, an LP has been available in Germany. We prospectively compared the safety profile of ECC and LP in preterm infants with apnea of prematurity. Methods: Between April 2010 and April 2013, selected side effects occurring with ECC or LP were documented in 6 German NICUs for infants ≤34 weeks' gestation using a longitudinal study design. The software developed for daily prescriptions in NICU residents requires entries if any of the following symptoms occurred during the last 24 h: tachycardia (resting heart rate >200/min), clinical or encephalographic seizures, gastric residuals, vomiting, or necrotizing enterocolitis (NEC). ECC and LP were administered at identical doses (20 mg/kg/day loading, 5-10 mg/kg/day maintenance) and in similar formulations either orally or intravenously. Results: 562 infants with 14,590 treatment days on ECC and 538 infants with 12,813 treatment days on LP were evaluated. The mean gestational age was similar (29.20 weeks for ECC vs. 29.14 weeks for LP). No relevant differences were seen concerning tachycardia, gastric residuals, or vomiting, but ECC was associated with a higher risk of NEC (risk ratio: 2.68, 95% CI: 1.01-7.23, p = 0.047) and, albeit not significantly so, seizures (risk ratio: 1.91, 95% CI: 0.53-6.96, p = 0.35). Conclusion: This survey demonstrates a similar safety profile for both forms of caffeine citrate. The lower NEC and seizure rate seen with the LP is intriguing, but requires confirmation in a controlled study design.

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Section: Discussioncontrasting

confidence: 56%

Safety Profile Comparison between Extemporaneous and a Licensed Preparation of Caffeine Citrate in Preterm Infants with Apnea of Prematurity

Vatlach¹,

Arand²,

Engel

et al. 2013

Neonatology

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“…62 Necrotizing enterocolitis Retrospective studies have reported conflicting results regarding a potential association between caffeine treatment and necrotizing enterocolitis (NEC). 63,64 A post hoc analysis from a trial of caffeine therapy for AOP showed a trend toward more NEC in the caffeine compared with the placebo-treated group. 65 Importantly, however, the randomized CAP Trial observed no differences in the rates of NEC between the treatment groups (6.3% caffeine group, 6.7% placebo group, p = 0.63).…”

Section: Mechanisms Of Actionmentioning

confidence: 99%

Caffeine: an evidence-based success story in VLBW pharmacotherapy

Dobson

Hunt

2018

Pediatr Res

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Apnea of prematurity (AOP) is a common and pervasive problem in very low birth weight infants. Methylxanthines were reported >40 years ago to be an effective therapy and, by the early 2000s, caffeine had become the preferred methylxanthine because of its wide therapeutic index, excellent bioavailability, and longer half-life. A clinical trial to address unresolved questions and toxicity concerns, completed in 2004, confirmed significant benefits of caffeine therapy, including shorter duration of intubation and respiratory support, reduced incidence of chronic lung disease, decreased need for treatment of patent ductus arteriosus, reduced severity of retinopathy of prematurity, and improved motor and visual function. Cohort studies have now further delineated the benefits of initiation of therapy before 3 days postnatal age, and of higher maintenance doses to achieve incremental beneficial effects. This review summarizes the pivotal and in particular the most recent studies that have established the safety and efficacy of caffeine therapy for AOP and other respiratory and neurodevelopmental outcomes. Caffeine has a very favorable benefit-to-risk ratio, and has become one of the most prescribed and cost-effective pharmacotherapies in the NICU.

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“…A retrospective analysis of an association between caffeine and necrotizing enterocolitis (NEC) can be conducted in a few months using a neonatal intensive care unit (NICU) database with minimal expense. (6)…”

Section: Introductionmentioning

confidence: 99%

Epidemiology and Clinical Research Design, Part 1: Study Types

Manja

Lakshminrusimha

2014

NeoReviews

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Selecting the best available preventive and therapeutic measures to avoid disability and death is an important goal for all health care practitioners. To achieve this goal, we need to perform studies that determine the value of these measures. In this article, we discuss the possible study designs that can be used for evaluating new approaches to prevention and treatment. The gold standard study design is a randomized, controlled, double-blind trial. In many instances, a randomized controlled trial may not be ethically or practically feasible. Other study types, such as case series, case-control studies, cohort studies, cross-sectional studies, crossover designs, and open-label studies, may be required to hypothesize and evaluate the link between an exposure or predictor variable and an outcome variable. Various study types pertaining to neonatal-perinatal medicine are reviewed in this article.

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Association between caffeine citrate exposure and necrotizing enterocolitis in preterm infants

Cited by 14 publications

References 18 publications

Safety Profile Comparison between Extemporaneous and a Licensed Preparation of Caffeine Citrate in Preterm Infants with Apnea of Prematurity

Safety Profile Comparison between Extemporaneous and a Licensed Preparation of Caffeine Citrate in Preterm Infants with Apnea of Prematurity

Caffeine: an evidence-based success story in VLBW pharmacotherapy

Epidemiology and Clinical Research Design, Part 1: Study Types

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