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Fever Management in Children With Febrile Neutropenia

Primary Purpose

Fever

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Control Group (Only Algorithm of Febrile Neutropenia Management)
Experimental Group (Algorithm of Febrile Neutropenia Management+Cold Steam)
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fever focused on measuring Cold Steam, Body Temperature, Fever

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Acıbadem Health Group Maslak HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control Group (Only Algorithm of Febrile Neutropenia Management)

Experimental Group (Algorithm of Febrile Neutropenia Management+Cold Steam)

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Body temperature
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.

Secondary Outcome Measures

Full Information

First Posted
December 28, 2021
Last Updated
March 23, 2023
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT05189236
Brief Title
Fever Management in Children With Febrile Neutropenia
Official Title
The Effect of Cold Steam Application on Body Temperature in Fever Management in Children With Febrile Neutropenia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever
Keywords
Cold Steam, Body Temperature, Fever

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group (Only Algorithm of Febrile Neutropenia Management)
Arm Type
Other
Arm Description
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).
Arm Title
Experimental Group (Algorithm of Febrile Neutropenia Management+Cold Steam)
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Control Group (Only Algorithm of Febrile Neutropenia Management)
Intervention Description
Common Procedure Steps The child is admitted to the unit and evaluated. 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. The inclusion and exclusion criteria are evaluated. The group of the child to be included in the study is determined in accordance with the randomization order. The first section of the patient information and follow-up form is filled out. The algorithm of Febrile Neutropenia Management is applied. The room temperature is kept constant at 21-24 degrees. Procedure Steps for Control Group: Common procedure steps are followed. 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).
Intervention Type
Procedure
Intervention Name(s)
Experimental Group (Algorithm of Febrile Neutropenia Management+Cold Steam)
Intervention Description
Procedure Steps for Experiment Group: Common procedure steps are followed. 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). 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).
Primary Outcome Measure Information:
Title
Body temperature
Description
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.
Time Frame
From baseline to discharge (average 3 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zehra Kan Öntürk, Assist Prof
Phone
+902165004163
Email
zehra.kan@acibadem.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Buket Çakır, MSc. Nurse
Phone
+90212 304 5976
Email
buket.cakir@acibadem.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra Kan Öntürk, Assist Prof
Organizational Affiliation
Acibadem University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acıbadem Health Group Maslak Hospital
City
İstanbul
State/Province
Maslak
ZIP/Postal Code
34485
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Buket Çakır, MSc. Nurse
Phone
0212 304 5976
Email
buket.cakir@acibadem.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33511731
Citation
Anderson K, Bradford N, Edwards R, Nicholson J, Lockwood L, Clark JE. Improving management of fever in neutropenic children with cancer across multiple sites. Eur J Cancer Care (Engl). 2021 May;30(3):e13413. doi: 10.1111/ecc.13413. Epub 2021 Jan 28.
Results Reference
result
PubMed Identifier
34138848
Citation
Green C, Krafft H, Guyatt G, Martin D. Symptomatic fever management in children: A systematic review of national and international guidelines. PLoS One. 2021 Jun 17;16(6):e0245815. doi: 10.1371/journal.pone.0245815. eCollection 2021.
Results Reference
result
PubMed Identifier
22220223
Citation
Jung TH, Rho JH, Hwang JH, Lee JH, Cha SC, Woo SC. The effect of the humidifier on sore throat and cough after thyroidectomy. Korean J Anesthesiol. 2011 Dec;61(6):470-4. doi: 10.4097/kjae.2011.61.6.470. Epub 2011 Dec 20.
Results Reference
result
PubMed Identifier
30461508
Citation
Lehrnbecher T. Treatment of fever in neutropenia in pediatric oncology patients. Curr Opin Pediatr. 2019 Feb;31(1):35-40. doi: 10.1097/MOP.0000000000000708.
Results Reference
result
PubMed Identifier
30916887
Citation
Paolino J, Mariani J, Lucas A, Rupon J, Weinstein H, Abrams A, Friedmann A. Outcomes of a clinical pathway for primary outpatient management of pediatric patients with low-risk febrile neutropenia. Pediatr Blood Cancer. 2019 Jul;66(7):e27679. doi: 10.1002/pbc.27679. Epub 2019 Mar 27.
Results Reference
result
PubMed Identifier
29517953
Citation
Taplitz RA, Kennedy EB, Flowers CR. Outpatient Management of Fever and Neutropenia in Adults Treated for Malignancy: American Society of Clinical Oncology and Infectious Diseases Society of America Clinical Practice Guideline Update Summary. J Oncol Pract. 2018 Apr;14(4):250-255. doi: 10.1200/JOP.18.00016. Epub 2018 Mar 8. No abstract available.
Results Reference
result

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Fever Management in Children With Febrile Neutropenia

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