Fever Management in Children with Febrile Neutropenia

NCT05189236 | Completed

• 1 other identifier: ATADEK-Clinical Trials 2021/18
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Fever

Keywords

Cold Steam; Body Temperature; Fever

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to discharge (average 3 days)

Study Arms (2)

Control Group (Only Algorithm of Febrile Neutropenia Management)

OTHER

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)

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

EXPERIMENTAL

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)

Interventions

Control Group (Only Algorithm of Febrile Neutropenia Management) 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).

Control Group (Only Algorithm of Febrile Neutropenia Management)

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

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

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• The children who have received a treatment protocol other than the algorithm of neutropenia management will be excluded from the study.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem Health Group Maslak Hospital

Istanbul, Maslak, 34485, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 33511731 BACKGROUND

• 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.

  PMID: 34138848 BACKGROUND

• 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.

  PMID: 22220223 BACKGROUND

• 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.

  PMID: 30461508 BACKGROUND

• 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.

  PMID: 30916887 BACKGROUND

• 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.

  PMID: 29517953 BACKGROUND

MeSH Terms

Conditions

Fever

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Zehra Kan Öntürk, Assist Prof

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: January 12, 2022
• Study Start: October 11, 2021
• Primary Completion: July 4, 2023
• Study Completion: July 4, 2023
• Last Updated: March 5, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)