Fever Management in Children with Febrile Neutropenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-11

Study Completion Date

2023-07-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fever

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

Control Group (Only Algorithm of Febrile Neutropenia Management)

Intervention Type PROCEDURE

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).

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).

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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).

Interventions

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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).

Intervention Type 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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