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FeBRILe3 Project - Fever, Blood cultures and Readiness for discharge in Infants Less than 3 months old.

FeBRILe3 Project - Fever, Blood cultures and Readiness for discharge in Infants Less than 3 months old. A prospective safety monitoring programme of a safety cohort of low risk infants less than 3 months old admitted with fever without source after the implementation of a new clinical practice guideline allowing for early discharge of well-appearing, low-risk infants.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619001010189
Acronym
FeBRILe3
Enrollment
500
Registered
2019-07-15
Start date
2019-08-06
Completion date
2021-12-04
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The FeBRILe3 project aims to look at the safety of earlier discharge home for well-looking, low-risk infants admitted to hospital with fever. It will monitor for unplanned hospital presentations or readmissions and other complications to show the safety and impact of this intervention in the WA population. We will collect information about all infants under 3 months old admitted to hospital with fever to provide further information about their signs and symptoms, investigation results, and diagnoses. We will also ask additional information from care-givers to understand their experience of during and after their hospital stay. We expect this information will help guide further management strategies to improve patient care and the hospital experience.

Interventions

This project will prospectively monitor a cohort of low risk infants less than 3 months old admitted with fever without source after the implementation of a new clinical practice guideline allowing for early discharge of well-appearing, low risk infants. This clinical practice guideline was created by the General Paediatric Departments at Perth Children's Hospital and Fiona Stanley Hospital based on evidence from the literature, indicating that most low-risk infants who warrant hospitalisation c

This project will prospectively monitor a cohort of low risk infants less than 3 months old admitted with fever without source after the implementation of a new clinical practice guideline allowing for early discharge of well-appearing, low risk infants. This clinical practice guideline was created by the General Paediatric Departments at Perth Children's Hospital and Fiona Stanley Hospital based on evidence from the literature, indicating that most low-risk infants who warrant hospitalisation can be safely discharged after 24 hours (Biondi 2015, Gomez 2016), and has been implemented at both hospitals. The FeBRILe3 project has been designed as an adjunct to the implemented guideline to monitor patient outcomes and safety prospectively following changes in healthcare policy, rather than delayed retrospective review of outcomes after a period of time post-implementation. As per the implemented clinical practice guideline, infants admitted for investigation of fever without source will be eligible for discharge after 24 hours if they fulfil all low-risk criteria and have no growth on blood cultures at 24 hours. Low-risk criteria include: i) age greater than or equal to 29 days, ii) absence of pyuria (no white cells in urine, i.e. <10 per high powered field), iii) CRP < 20 mg/l, iv) absolute neutrophil count (ANC) < 10 x 10^9/L and white cell count (WCC) between 4 x 10^9/L and 15 x 10^9/L, v) have not received antibiotics within 48 hours prior to admission and vi) appear well on examination. High risk infants (appearing unwell/toxic, < 28 days old, or with significant medical comorbidities), those who remain clinically unwell or who have investigative tests suggestive of a serious bacterial infection (e.g. urinary tract infection, bacteraemia or meningitis) will be admitted for a minimum of 48 hours, with management directed by clinical status as per current practice. The safety of this new clinical practice guideline allowing early discharge of low-risk infants will be determined by active monitoring of unplanned hospital re-presentation/readmissions rates within 7 days of discharge (through electronic admission details and care-giver surveys) for the first 500 patients (for a study period of up to 24 months) after implementation of the new clinical practice guideline. Baseline demographic and clinical information will be collected for all infants aged less than 3 months old (chronological or corrected for premature birth before 37 weeks gestation) admitted to hospital for the investigation and management of fever. Care-givers will have the option to opt out of SMS/telephone survey follow-up. Biondi EA, Byington CL. Evaluation and Management of Febrile, Well-appearing Young Infants. Infectious Disease Clinics of North America. 2015;29(3):575-585. Gomez B, Mintegi S, Bressan S, et al. Validation of the "Step-by-Step" Approach in the Management of Young Febrile Infants. Pediatrics. Aug 2016;138(2).

Sponsors

Telethon Kids Institute
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
0 to 90 Days
Healthy volunteers
No

Inclusion criteria

1. Aged less than 90 days chronological age for term infants; or less than 90 days since 40 weeks gestation if born before 37 weeks gestation 2. Admitted to participating hospital for the primary reason of investigation and management of fever without source

Exclusion criteria

Any infant never separated from hospital since birth.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 18, 2026