DIStinguishing ChildrEn at Low Risk of Severe infectioN in Case of Febrile Neutropenia-7: Impact Study of a Clinical Decision Rule
- Conditions
- Neutropenia, Febrile
- Interventions
- Procedure: The Clinical Decision Rule
- Registration Number
- NCT04938206
- Lead Sponsor
- University Hospital, Lille
- Brief Summary
Febrile neutropenia (NF) is the leading cause of unscheduled hospitalization in children with cancer. Management classically involves emergency admission to hospital for intravenous antibiotic treatment until resolution of fever and neutropenia. However, children with NF are a heterogeneous group with varying risks of severe infection (10-29%). This approach, which is recognized as excessive for low-risk episodes of severe infection, particularly in terms of quality of life and cost, is no longer recommended. Management should move to a more personalized model that takes into account the individual probability of severe infection. Clinical decision rules (CDRs) have been proposed to facilitate risk stratification, but none are useful in our French population because of insufficient reproducibility or effectiveness.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1480
- Followed for hemopathy or cancer,
- Presenting with post-chemotherapy NF,
- With social security coverage,
- With parents able to provide appropriate home supervision,
- Consent of parents and child if able to give consent.
- NF to diagnosis of tumor disease,
- Child with palliative care,
- Child who has had an allogeneic hematopoietic stem cell transplant within the past year,
- NF immediately following an autologous hematopoietic stem cell transplant,
- Participation in the study during a previous NF,
- Curative antibiotic therapy or documented infection prior to admission,
- Initial management at a non-investigative center,
- Refusal of the child or parents to participate
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description management reduction strategy The Clinical Decision Rule Patients classified as low risk by the DRC who will have a reduction in the management of their post-chemotherapy NF. standard management The Clinical Decision Rule Patients classified as low risk by the DRC who will have standard management of post-chemotherapy NF.
- Primary Outcome Measures
Name Time Method Change in quality of life score, calculated from the PedsQL™ scale between inclusion and Day 6. at day 6 The Pediatric Quality of Life Inventory (PedsQL) is a brief measure of health-related quality of life in children and young people. The measure can be completed by parents (the Proxy Report) as well as children and young people (the Self-Report).
On the PedsQL Generic Core Scales, for ease of interpretability, items are reversed scored and linearly transformed to a 0-100 scale, so that higher scores indicate better HRQOL (Health-Related Quality of Life).
To reverse score, transform the 0-4 scale items to 0-100 as follows: 0=100, 1=75, 2=50, 3=25, 4=0.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hop Jeanne de Flandre Chu Lille
🇫🇷Lille, France