Fever and Shivering: Frequency and Role in Predicting Serious Bacterial Infection

Study Overview
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Brief Summary
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Febrile shivering in the pediatric population is assumed to be related to a Severe Bacterial Infection (SBI). Research supporting this assumption is scant. The purpose of this study is to describe the frequency of febrile shivering in the pediatric population arriving at the emergency department and to define its role in predicting a SBI.

Detailed Description
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Background: Fever is a common complaint and lacking localizing signs poses a diagnostic dilemma, mostly, but not only, in children under 3 years of age. Recent years studies found common clinical markers for a Serious Bacterial Infection (SBI) to be ineffective in confirming or ruling out a suspected SBI in an environment with low prevalence of SBI such as developed countries. Shivering (chills, rigors) during a febrile illness is a common complaint in children but it's true incidence is unknown. It is assumed that shivering appears more frequently in children with SBI but only one study in the pediatric population was found to support this assumption. No studies were found to describe the frequency of shivering in the emergency department. Study purpose: To describe the frequency of febrile shivering in the pediatric population arriving at the emergency department and it's relation to a Severe Bacterial Infection. Participants: Children in the age range of 3 months to 18 years presenting with fever. Intervention: During the study time frame the frequency of febrile shivering will be documented . Patients with febrile shivering who meet the inclusion criteria, a sepsis workup will be done including blood samples for inflammatory markers, blood culture, urinalysis and urine culture when a urinary tact infection is suspected. Other systems (CSF sampling, joint fluid aspiration, stool culture, chest x ray) will be examined according to an appropriate history and clinical suspicion. The same work up will be done in next consecutive patient presenting with fever without shivering. Results: The frequency of febrile shivering, positive cultures, lobar pneumonia in a chest x ray. A comparison between the study and the control group will be made. Categorical variables will be compared using the Chi square test or Fisher exact test (as appropriate). Continuous variables will be compared using the student t test or Mann Whitney test. The relation between a bacterial infection and clinical variables will be analyzed using a logistic regression. Study group size: This is a pilot study. Investigators will use a convenience sample of all children admitted with shivering during the study period. Safety: All examinations will be held by the emergency department organic staff in the same routine methods done otherwise outside the study settings. The emergency department and hospital protocols for patients identification and infection control will be carried out before invasive procedures. Ethics: Parents will be asked for their agreement to answer a questioner as part of the study and their agreement will be documented. Informed consent will be asked for each patient, of the legal guardian. The study will be held according to the ethics rules of the Helsinki declaration and was approved by the local Ethics board. Access to the database will be restricted to the study investigators. The database will be encrypted by a password. After gathering the data and before statistical analysis information identifying the patients will be removed. The importance of the study: Fever in children is a common complaint frequently posing a dilemma on the extent of workup needed beyond clinical evaluation. This study aims to examine the frequency of shivering among children presenting to the ED with fever , its ability to predict the risk of severe bacterial infection.

Official Title
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Fever and Shivering: Frequency Among Children Visiting the Emergency Department and Its Role in Predicting Serious Bacterial Infection

Conditions
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Febrile Shivering, Severe Bacterial Infection

Intervention / Treatment
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* Other: Ancillary tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: fever at least during the last day shivering during current febrile illness no shivering during current febrile illness if recruited to the control group Exclusion Criteria: (for cases and controls) immune deficiency antibiotics treatment up to 48 hours before the presentation presentation following febrile convulsion non Hebrew speaking guardians

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Febrile Shivering<br> | Other: Ancillary tests<br>* Blood culture, complete blood count, crp, urinalysis for all patients. If clinically indicated: Urine culture, chest x ray, csf culture, stool culture, joint fluid culture<br>|
| Fever without Shivering<br> | Other: Ancillary tests<br>* Blood culture, complete blood count, crp, urinalysis for all patients. If clinically indicated: Urine culture, chest x ray, csf culture, stool culture, joint fluid culture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of febrile children who experienced shivering | Proportion of febrile children who experienced shivering | Within 7 days from the beginning of fever | 
| Severe bacterial infection | positive blood cultures (not including common skin pathogens / contaminants), Positive urine culture, Positive csf culture, Alveolar Infiltrate on CXR, positive joint fluid culture. The number of patients who had at least one positive result in the above mentioned parameters. | Within 7 days from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High inflammatory markers | The number of patients who had CRP higher than twice the normal range or WBC higher than 15,000. | Within 24 hours of enrollment | 
| Antibiotics Treatment | number of patients treated with antibiotics | Within 24 hours of enrollment | 
| hospitalization | number of patients admitted to the hospital | Within 24 hours of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fever, shivering, chills, rigors, severe bacterial infection