Krafft Hanno S, Raak Christa K, Jenetzky Ekkehart, Zuzak Tycho J, Längler Alfred, Martin David D
Faculty of Health/School of Medicine, Witten/Herdecke University, Alfred-Herrhausen-Straße 50, 58448, Witten, Germany.
Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center of the Johannes-Gutenberg-University, Mainz, Germany.
Pilot Feasibility Stud. 2022 Aug 16;8(1):183. doi: 10.1186/s40814-022-01144-7.
Fever in children is a major problem in pediatric oncology. Usual management leads to immediate antibiotic and antipyretic therapy, although there is consensus that antipyretic therapy should not be utilized with the sole aim of reducing body temperature. Increased body temperature during fever appears to be an effective modifier in terms of viral replication and enhanced host defense mechanisms against pathogens. Therefore, it might be beneficial to support febrile patients by applying gentle heat during the onset of fever to help the body to reach its new thermoregulatory set point.
A randomized pilot study over 6 months will be conducted in a pediatric oncology department in an academic hospital in Germany. This study is a preparation for a multicenter clinical trial with two parallel groups concerning the efficacy of heat application vs. treatment as usual. One of the inclusion criteria is body temperatures ≥ 38.0 °C in n = 24 cases of patients receiving chemotherapy aged 18 months to 17 years. The first intervention consists of gentle heat application with hot water bottles at any sign of illness and onset of fever. The aim is to achieve a warm periphery equilibrated to trunk temperature of less than 0.5 °C. The second intervention is the avoidance of antipyretics. The control group receives the standard antipyretic treatment from the participating hospital. The purposes of this pilot study are proof of principle of intervention, evaluation of safety, feasibility, definition of endpoints, and to receive basic data for sample size calculation and needed resources.
The main goal is to improve the care of children with cancer by providing the best possible support for febrile episodes. If fever support by heat reduces discomfort, administration of antipyretics and maybe even antibiotics, this would be an advancement in oncological fever management. This pilot study is intended to provide a basis for a main, multicenter, randomized trial and demonstrate the practicability of heat application in febrile patients in pediatric oncology.
German Clinical Trials Register (DRKS), DRKS00028273 . Registered on 14 April 2022.
儿童发热是儿科肿瘤学中的一个主要问题。常规治疗通常会立即进行抗生素和退热治疗，尽管人们普遍认为不应仅以降低体温为目的使用退热治疗。发热期间体温升高似乎是病毒复制和增强宿主对病原体防御机制方面的一种有效调节因素。因此，在发热开始时对发热患者进行适度加热以帮助身体达到新的体温调节设定点可能是有益的。
将在德国一家学术医院的儿科肿瘤科室进行一项为期6个月的随机试点研究。本研究是一项多中心临床试验的准备工作，该试验有两个平行组，分别研究加热应用与常规治疗的疗效。纳入标准之一是n = 24例年龄在18个月至17岁接受化疗的患者体温≥38.0°C。首次干预包括在出现任何疾病迹象和发热开始时用热水瓶进行适度加热。目标是使外周温度与躯干温度达到平衡，温差小于0.5°C。第二次干预是避免使用退烧药。对照组接受参与医院的标准退热治疗。本试点研究的目的是验证干预的原理、评估安全性、可行性、确定终点，并获取样本量计算和所需资源的基础数据。
主要目标是通过为发热发作提供尽可能好的支持来改善癌症患儿的护理。如果通过加热支持发热能减轻不适、减少退烧药甚至抗生素的使用，这将是肿瘤发热管理方面的一项进步。本试点研究旨在为一项主要的多中心随机试验提供基础，并证明在儿科肿瘤学中对发热患者应用加热的实用性。
德国临床试验注册中心（DRKS），DRKS00028273。于2022年4月14日注册。
