JMIR Publications

ABSTRACT

Background:

Hypothermia in young infants presenting to the emergency department (ED) may indicate a serious bacterial infection (SBI) such as a urinary tract infection, bacteremia, or bacterial meningitis. Improved understanding of the epidemiology of SBI in hypothermic infants and the development of prediction models can help avoid unnecessary invasive procedures and antimicrobial exposure. The objectives of this multicenter study are to (1) describe the epidemiology of SBI and HSV among hypothermic infants, (2) assess the role of biomarkers in predicting SBI, and (3) derive and internally validate a multivariable predictive model for SBI among hypothermic infants.

Objective:

The objectives of this multicenter study are to (1) describe the epidemiology of SBI and HSV among hypothermic infants, (2) assess the role of biomarkers in predicting SBI, and (3) derive and internally validate a multivariable predictive model for SBI among hypothermic infants.

Methods:

The study is being conducted through the Pediatric Emergency Medicine Collaborative Research Committee (PEMCRC) as a retrospective nested case-control study. We will include infants with hypothermia (rectal temperature <36.5 °C) presenting to one of 30 pediatric EDs in the United States between January 1, 2013, and December 31, 2022. Exclusion criteria will include (1) fever in the ED or prior to ED arrival, (2) transfer from another healthcare facility, (3) technology dependence, (4) trauma, (5) skin and soft tissue infections, and (6) presentation in cardiac arrest. The primary outcomes will be culture-confirmed SBI (objectives 1-3) and HSV-positivity (objective 1). The analytic approach for each objective will be to (1) use descriptive statistics to summarize the epidemiology of SBI and HSV and clinical outcomes, (2) compare biomarker parameters of infants with and without SBI and determine optimal cut-off values using a receiver operator characteristic curve, and (3) develop a multivariable predictive model using penalized mixed effects logistic regression within a 1:3 case-control sample among infants in the cohort who had a blood culture obtained.

Results:

Data collection for this study is ongoing, with collection of data from 13 hospitals at the time of protocol submission.

Conclusions:

We will use a consensus-based outcome measure for SBI with an established data acquisition pathway. We will use a multicenter sample from 30 U.S. children's hospitals, employing a consensus-based outcome measure for SBI and a case-control approach to effectively evaluate rare outcomes to improve the management of young infants with hypothermia in the emergency department.