Risk Factors for Serious Bacterial Infections Among Young Infants With Hypothermia: Protocol for a Multicenter, Retrospective Case-Control Study
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 infants with hypothermia and the development of prediction models can help avoid unnecessary invasive procedures and antimicrobial exposure. Objective The aim of the study is to (1) describe the epidemiology of SBI and herpes simplex virus (HSV) among infants with hypothermia, (2) assess the role of biomarkers in predicting SBI, and (3) derive and internally validate a multivariable predictive model for SBI among infants with hypothermia. Methods The study is being conducted through the Pediatric Emergency Medicine Collaborative Research Committee as a retrospective nested case-control study. We will include infants with hypothermia (rectal temperature<36.5 °C) presenting to 1 of 28 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 health care 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 (1) to use descriptive statistics to summarize the epidemiology of SBI and…
How strong is the evidence?
Evidence Hub reads this as a case-control, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause. Reported size: 45,673 participants or records.
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