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CTRI Number  CTRI/2025/11/097049 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 06/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Timely administration of antibiotics in children with febrile neutropenia 
Scientific Title of Study   Golden hour in children with febrile neutropenia; a quality improvement initiative 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Emine A Rahiman 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Room no 5, Women and Child Block, Kasturba Medical College, Manipal
Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India 
Phone  09878169259  
Fax    
Email  dreminearahiman@yahoo.in  
 
Details of Contact Person
Scientific Query
 
Name  Emine A Rahiman 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Room no 5, Women and Child Block, Kasturba Medical College, Manipal
Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India 
Phone  09878169259  
Fax    
Email  dreminearahiman@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Emine A Rahiman 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Room no 5, Women and Child Block, Kasturba Medical College, Manipal
Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India 
Phone  09878169259  
Fax    
Email  dreminearahiman@yahoo.in  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal, Karnataka, India, 576104 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Madhav Nagar, Manipal, Karnataka 576104 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Emine A Rahiman  Kasturba Medical College  Department of Pediatric Oncology, Room no 5, Women and Children Block, Kasturba Medical College, Madhav Nagar, Udupi, Karnataka
Udupi
KARNATAKA 
09878169259

dreminearahiman@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Compliance to SOP  Ensuring compliance to unit SOP regarding febrile neutropenia monthly This will be done for duration of 1 PDSA cycle and if found to be impactful for the remaining duration of project  
Intervention  Creation and distribution of education material  Giving handout regarding febrile neutropenia to patients and caregivers This will be done for duration of 1 PDSA cycle and if found to be impactful for the remaining duration of project  
Intervention  education  Specific education regarding febrile neutropenia and importance of antibiotics at first discharge This will be done for duration of 1 PDSA cycle and if found to be impactful for the remaining duration of project  
Intervention  education of healthcare providers  Education of junior/on-call/on-floor residents regarding febrile neutropenia and SOP of the unit This will be done for duration of 1 PDSA cycle and if found to be impactful for the remaining duration of project  
Intervention  Ensuring fever is identified on time  Ensuring availability of functional thermometer and educating caregiver regarding recording of temperature This will be done for duration of 1 PDSA cycle and if found to be impactful for the remaining duration of project  
Comparator Agent  not applicable  not applicable 
Intervention  re-inforcement of education  Re-inforcement of same education once a month in monthly patient support groups This will be done for duration of 1 PDSA cycle and if found to be impactful for the remaining duration of project  
Intervention  Triage of patients in OPD  Streamlining of febrile neutropenia patients in OPD This will be done for duration of 1 PDSA cycle and if found to be impactful for the remaining duration of project  
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
compliance for 1-hour interval from onset of fever to antibiotic administration in children with febrile neutropenia undergoing treatment for childhood cancer  at the end of project- 1 year from starting  
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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

 
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