Fever Management in Children with Febrile Neutropenia

Not Applicable

Completed

• Conditions: Fever
• Interventions: Procedure: Experimental Group (Algorithm of Febrile Neutropenia Management+Cold Steam); Procedure: Control Group (Only Algorithm of Febrile Neutropenia Management)

• Registration Number: NCT05189236
• Lead Sponsor: Acibadem University

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 Timeline

• Study Start: 2021-10-11
• Study First Submitted: 2021-12-28
• Study First Submitted QC: 2021-12-28
• Study First Posted: 2022-01-12
• Status Verified: 2023-07
• Primary Completion: 2023-07-04
• Study Completion: 2023-07-04
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group (Algorithm of Febrile Neutropenia Management+Cold Steam)	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).
Control Group (Only Algorithm of Febrile Neutropenia Management)	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).

Primary Outcome Measures

Name	Time	Method
Body temperature	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.

Trial Locations

Locations (1)

Acıbadem Health Group Maslak Hospital; 🇹🇷 İstanbul, Maslak, Turkey