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Fever Management in Children With Febrile Neutropenia

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ClinicalTrials.gov Identifier: NCT05189236
Recruitment Status : Recruiting
First Posted : January 12, 2022
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
Zehra Kan Onturk, Acibadem University

Tracking Information
First Submitted Date  ICMJE December 28, 2021
First Posted Date  ICMJE January 12, 2022
Last Update Posted Date April 28, 2022
Actual Study Start Date  ICMJE October 11, 2021
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2021)
Body temperature [ Time Frame: From baseline to discharge (average 3 days) ]
The body temperature values of patients in the experimental and control groups will be compared (from baseline to discharge (average 3 days). Body temperature measurement will be evaluated as axillary.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fever Management in Children With Febrile Neutropenia
Official Title  ICMJE The Effect of Cold Steam Application on Body Temperature in Fever Management in Children With Febrile Neutropenia
Brief Summary The aim of this study is to determine the effect of the cold steam application on body temperature in combination with the treatment algorithm in fever management in children with febrile neutropenia.
Detailed Description

Fever and neutropenia are common side effects of the myelosuppressive chemotherapy paediatric oncology patients undergo. This is one of the most prevalent causes of non-elective hospitalizations in patients in the population, accounting for 19% of patient applications. The fever that develops with neutropenia can result in significant complications, including brain damage, seizures and death. Therefore, it is critical to follow up patients at risk for signs and symptoms of infection, such as fever, chills or sweating, and to ensure effective fever management.

This research was designed to be conducted as a randomised controlled experiment study until the entire sample group identified in the Paediatric Oncology Service was reached. The algorithm of neutropenia management is used to treat children who are followed up at the paediatric oncology service, where the study will be conducted, due to febrile neutropenia. The control group will consist of children who have been treated using this algorithm (only the algorithm); whereas, the experimental group will consist of the children who will be applied to cold stream in addition to this algorithm (the algorithm + cold steam application). The body temperature values of patients in the experimental and control groups will be compared (from baseline to discharge (average 3 days)).

Cold Steam Application A nebulizer is positioned in the room, and the hose end, through which the steam is released, is supplied to the ambient air and operated in continuous mode during the cold steam application.

An Atom Sanilizer 30 ultrasonic nebulizer will be used to supply cold steam to every patient. The steam capacity of the device is 2.5 ml./min., the output power is 30 W.

The nebulizer will be used solely in the patient's room from the time the patient is admitted until his temperature is stabilised. During the private use period, the machine will not be exchanged between patients. During patient use, the device is cleaned with alcohol-based rapid surface disinfectant once a day. If another patient needs it, another device in the clinic will be utilized. The unit and the hospital already have a sufficient number of devices. After the patients' usage of the nebulizer is ended, the appliance is cleaned by using an alcohol-based rapid surface disinfectant, and the accessories are sterilized with a medium-level disinfectant in the Central Sterilization Unit.

During the practice of cold steam, if the body temperature falls within the usual range (axillary 36-37 0C, tympanic 36.5-37.7 0C), the practice will be discontinued and possible hypothermia will be avoided.

Procedures to follow in the development of hypothermia;

  • ABC is evaluated.
  • He is monitorised.

    -If there is no pulse, Advanced Life Support begins.

  • A warm ambient is provided.
  • He is warmed up with a blanket.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Fever
Intervention  ICMJE
  • Procedure: Control Group (Only Algorithm of Febrile Neutropenia Management)

    Common Procedure Steps

    1. The child is admitted to the unit and evaluated.
    2. The objective of the study is explained to the children and children's parents, and their consent is obtained after they have read and signed the informed consent form.
    3. The inclusion and exclusion criteria are evaluated.
    4. The group of the child to be included in the study is determined in accordance with the randomization order.
    5. The first section of the patient information and follow-up form is filled out.
    6. The algorithm of Febrile Neutropenia Management is applied. The room temperature is kept constant at 21-24 degrees.

    Procedure Steps for Control Group:

    1. Common procedure steps are followed.
    2. The body temperature of the child are recorded in the second section of the Patient Information and Follow-up Form until the fever is kept under control (until the discharge criteria are met, - 72 hours without fever and the culture result is negative).
  • Procedure: Experimental Group (Algorithm of Febrile Neutropenia Management+Cold Steam)

    Procedure Steps for Experiment Group:

    1. Common procedure steps are followed.
    2. Cold steam is continuously applied until the fever is kept under control (until the discharge criteria are met, - 72 hours without fever and the culture result is negative).
    3. The body temperature of the child are recorded in the second section of the Patient Information and Follow-up Form from the time the patient is admitted until the fever is kept under control (until the discharge criteria are met, - 72 hours without fever and the culture result is negative).
Study Arms  ICMJE
  • Control Group (Only Algorithm of Febrile Neutropenia Management)
    The algorithm of febril neutropenia management is used to treat children who are followed up at the paediatric oncology service, where the study will be conducted, due to febrile neutropenia. The control group will consist of children who have been treated using this algorithm (only the Algorithm of Febrile Neutropenia Management).
    Intervention: Procedure: Control Group (Only Algorithm of Febrile Neutropenia Management)
  • Experimental: Experimental Group (Algorithm of Febrile Neutropenia Management+Cold Steam)
    The experimental group will consist of the children who will be applied to cold steam in addition to this algorithm (Algorithm of Febrile Neutropenia Management + cold steam application).
    Intervention: Procedure: Experimental Group (Algorithm of Febrile Neutropenia Management+Cold Steam)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 28, 2021)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The children and/or children's parents have agreed to participate in the study and have signed the informed consent form and
  • Who are from the age of one month to eighteen years old,
  • Children treated for febrile neutropenia
  • Have a stable clinical condition will be included in the study

Exclusion Criteria:

  • The children who have received a treatment protocol other than the algorithm of neutropenia management will be excluded from the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zehra Kan Öntürk, Assist Prof +902165004163 zehra.kan@acibadem.edu.tr
Contact: Buket Çakır, MSc. Nurse +90212 304 5976 buket.cakir@acibadem.com
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05189236
Other Study ID Numbers  ICMJE ATADEK-Clinical Trials 2021/18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zehra Kan Onturk, Acibadem University
Study Sponsor  ICMJE Acibadem University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zehra Kan Öntürk, Assist Prof Acibadem University
PRS Account Acibadem University
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP