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临床试验/CTRI/2025/11/097049
CTRI/2025/11/097049尚未招募不适用

Golden hour in children with febrile neutropenia; a quality improvement initiative

Kasturba Medical College1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
compliance for 1-hour interval from onset of fever to antibiotic administration in children with febrile neutropenia undergoing treatment for childhood cancer

研究概览

简要总结

The study aims to reduce the duration from the onset of fever to administration of first dose of antibiotics in non-hospitalised children with febrile neutropenia from the current average of 2 hours to less than 1 hour from 25% to 75% episodes.

Justification of the study is to ensure timely administration of antibiotics in febrile neutropenia as  Delay in antibiotic delivery leads to a higher risk of developing sepsis, septic shock, and higher requirement of inotropic support, increased risk of transfer to ICU, thus burdening the health care system and increasing the cost of therapy. Hence, ensuring timely antibiotic administration is the most important tool in supportive care management of children with cancer.

The study will be held in the Department of Pediatric Oncology.

This is a prospective Quality Improvement project where the Study Population are Children less than 18 years receiving Intensive chemotherapy and residing within 5 km radius from the hospital with Febrile neutropenia.

Details of children on intensive chemotherapy with temperature >/= 100.5 0F and Absolute Neutrophil Count < 1500 coming to pediatric hematology and oncology OPD/Daycare/ward will be enrolled. Details of 1st documentation of fever, time of contact with health care provider and the time of administration of 1st dose of IV antibiotics will be recorded in an Excel spreadsheet. Then a run chart is created for showing project baseline and target. Tools such as pareto, 5 whys, or impact/feasibility matrix and identify vital few root causes shall be used. After identifying 3-5 key drivers for the project and a few potential specific interventions that would address the key drivers will be decided. Based on the key drivers feasible interventions will be planned and changes shall be recorded. Based on measure of impact decisions on interventions to adapt, adopt, or abandon will be made. Finally, a sustainability plan is made.

The probable causes/keydrivers of delay in administration of the first dose of antibiotics could be

 1.         Lack of knowledge of caregivers on the importance of febrile neutropenia

2.         Lack of knowledge of caregivers on identification of fever

3.         Communication failure with healthcare provider for fever episode

4.         Difficulty in intravenous access

5.         Lack of knowledge of caregivers with regards to admission or daycare process

6.         Self- prescription of anti-pyretics

7.         Healthcare provider delay for decision of antibiotics

8.         Nonavailability of healthcare personnel for administration of antibiotics within time

9.         Travel related issues and delay to reach hospital

10.       Non-availability of bed

The probable interventions are

1.         Specific education regarding febrile neutropenia and importance of antibiotics at first discharge

2.         Ensuring availability of functional thermometer and educating caregiver regarding recording of temperature

3.         Re-inforcement of same education once a month in monthly patient support groups

4.         Giving handout regarding febrile neutropenia to patients and caregivers

5.         Education of junior/on-call/on-floor residents regarding febrile neutropenia and SOP of the unit

6.         Streamlining of fever patients in OPD

7.         Ensuring compliance to unit SOP regarding febrile neutropenia monthly

10 febrile neutropenia episodes are planned per Plan-Do-Study-Act (PDSA) cycle; Approximately we have 5 febrile neutropenia episodes in 2 weeks who fulfill the criteria. Hence each cycle would approximately take 1.5 - 2 months each. Hence arbitrarily, a sample size of 10 episodes has been chosen.

4- 5 PDSA Cycles over approximately 50 Febrile neutropenia episodes is estimated

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
1.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • All pediatric patients (1-18 years) diagnosed with malignancy on intensive chemotherapy who have documented fever and are residing within a 5km radius of the hospital, and are currently not hospitalized.

排除标准

  • Pediatric patients with cancer , not on intensive chemotherapy and has documented fever and reside outside a radius of 5 km from the hospital AND patients who are undergoing intensive chemotherapy but are admitted when fever was identified.

结局指标

主要结局

compliance for 1-hour interval from onset of fever to antibiotic administration in children with febrile neutropenia undergoing treatment for childhood cancer

时间窗: at the end of project- 1 year from starting

次要结局

  • median time from fever to call healthcare professional(6 months & 12 months)
  • Median time from arrival to antibiotic administration(6 months & 12 months)
  • Proportion of episodes in which antibiotics given but child not neutropenic(6 months & 12 months)
  • Incidence of failed chemoport access & cannula inserted(6 months & 12 months)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Emine A Rahiman

Kasturba Medical College, Manipal

研究点 (1)

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