Objectives To develop and validate a prediction rule to identify well-appearing febrile infants aged ≤90 days with an abnormal urine dipstick at low risk of invasive bacterial infections (IBIs, bacteraemia or bacterial meningitis).
Design Ambispective, multicentre study.
Setting The derivation set in a single paediatric emergency department (ED) between 2003 and 2017. The validation set in 21 European EDs between December 2017 and November 2019.
Patients Two sets of well-appearing febrile infants aged ≤90 days with an abnormal urine dipstick (either leucocyte esterase and/or nitrite positive test).
Main outcome Prevalence of IBI in low-risk infants according to the RISeuP score.
Results We included 662 infants in the derivation set (IBI rate:5.2%). After logistic regression, we developed a score (RISeuP score) including age (≤15 days old), serum procalcitonin (≥0.6 ng/mL) and C reactive protein (≥20 mg/L) as risk factors. The absence of any risk factor had a sensitivity of 96.0% (95% CI 80.5% to 99.3%), a negative predictive value of 99.4% (95% CI 96.4% to 99.9%) and a specificity of 32.9% (95% CI 28.8% to 37.3%) for ruling out an IBI. Applying it in the 449 infants of the validation set (IBI rate 4.9%), sensitivity, negative predictive value and specificity were 100% (95% CI 87.1% to 100%), 100% (95% CI 97.3% to 100%) and 29.7% (95% CI 25.8% to 33.8%), respectively.
Conclusion This prediction rule accurately identified well-appearing febrile infants aged ≤90 days with an abnormal urine dipstick at low risk of IBI. This score can be used to guide initial clinical decision-making in these patients, selecting infants suitable for an outpatient management.
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Twitter @quetzal1980, @MintegiSanti
Contributors RV conceptualised and designed the study, analysed the data, wrote the initial draft of the manuscript,and approved the final manuscript as submitted. AL collaborated in the data collection, revised multiple versions of the initial manuscript and critically reviewed the final manuscript. BG and MdlT collaborated in the design of the study and in the data collection, revised multiple versions of the initial manuscript and critically reviewed the final manuscript. ID, AC, DdlR, SMa, JR, AG, A-AL, AR, IM, CMA, SMi, SC, JA, PdR, ES, IRdO, IN and BV reviewed, made suggestions and approved the initial version of the protocol, collaborated in the data collection and reviewed, made suggestions and approved the final manuscript as submitted. SMi conceptualised and designed the study, revised multiple versions of the initial manuscript and approved the final manuscript as submitted. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of the work.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This study was approved by the Western Valladolid Clinical Research Ethics Committee CEIC Internal Code 91/17. Derivation set: approval was obtained from the hospital ethics committee. Validation set: The clinical research ethics committee of the coordinating hospital and the institutional review boards of each participating institution approved the study (internal code 91/17). Informed consent was requested from parents or caregivers prior to the inclusion of patients in the validation set.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.
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