Clinical trial NCT05189236: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Keywords: Cold Steam
Body Temperature
Fever
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 34
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Body temperature
timeFrame: From baseline to discharge (average 3 days)
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acıbadem Health Group Maslak Hospital
state: Maslak
Study officials:
affiliation: Acibadem University
name: Zehra Kan Öntürk, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.