Risk Factors for Serious Bacterial Infections Among Young Infants With Hypothermia: Protocol for a Multicenter, Retrospective Case-Control Study
Bibliographic record
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 HSV and clinical outcomes, (2) to compare biomarker parameters of infants with and without SBI and determine optimal cutoff values using a receiver operator characteristic curve, and (3) to 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 a collection of data from 21 hospitals at the time of protocol submission. Of 16 sites evaluated in preliminary analysis (n=45,673), the median age is 25 (IQR 6-52) days, and 24,182 (52.9%) are male. In total, 340 (0.7%) infants have an SBI, of whom 103 had bacteremia or meningitis. Mortality occurred in 7 (2.1%; 95% CI 0.9%-4.3%). CONCLUSIONS: We will use a consensus-based outcome measure for SBI with an established data acquisition pathway. We will use a multicenter sample from US children's hospitals, using a consensus-based outcome measure for SBI and a case-control approach to evaluate outcomes to improve the management of young infants with hypothermia in the ED. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/66722.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".