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
|Condition or disease||Intervention/treatment||Phase|
|Fever||Procedure: Control Group (Only Algorithm of Febrile Neutropenia Management) Procedure: Experimental Group (Algorithm of Febrile Neutropenia Management+Cold Steam)||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effect of Cold Steam Application on Body Temperature in Fever Management in Children With Febrile Neutropenia|
|Actual Study Start Date :||October 11, 2021|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
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).
Procedure: Control Group (Only Algorithm of Febrile Neutropenia Management)
Common Procedure Steps
Procedure Steps for Control Group:
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).
Procedure: Experimental Group (Algorithm of Febrile Neutropenia Management+Cold Steam)
Procedure Steps for Experiment Group:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05189236
|Contact: Zehra Kan Öntürk, Assist Profemail@example.com|
|Contact: Buket Çakır, MSc. Nurse||+90212 304 firstname.lastname@example.org|
|Acıbadem Health Group Maslak Hospital||Recruiting|
|İstanbul, Maslak, Turkey, 34485|
|Contact: Buket Çakır, MSc. Nurse 0212 304 5976 email@example.com|
|Principal Investigator:||Zehra Kan Öntürk, Assist Prof||Acibadem University|