Fever Support in Pediatric Oncology (FeSuPO): A pilot study protocol for a multi-center randomized controlled tria
Not Applicable
Recruiting
- Conditions
- Fever
- Registration Number
- DRKS00028273
- Lead Sponsor
- niversität Witten/Herdecke, Fakultät für Gesundheit (Department für Humanmedizin)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Essential inclusion criteria: Presence of oncologic disease; Initiation of chemotherapy; Need for hospitalization due to a core body temperature = 38.5 °C within 3 months of chemotherapy initiation; Patients between the ages of 1 and 17 years; Informed consent from legal guardians and patient 14 years of age or older
Exclusion Criteria
Major exclusion criteria: Evidence of acute brain injury by computed tomography; Malignant hyperthermia (ever occurred); Neuroleptic malignant syndrome (ever occurred); Hepatic cirrhosis (ever occurred); Acute hepatic failure; History of stroke, seizure, or traumatic brain injury
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective of this pilot study (Eldridge et al., 2016) is <br>a.) proof of principle and definition of intervention, <br>b.) review and optimize operationalization of the intervention,<br>c.) evaluation of safety and feasibility of study design, <br>d.) including identification of contraindications to the intervention and termination criteria,<br>e.) definition of primary and secondary outcomes for main study, <br>f.) determination of required sample size and recruitment time,<br>g.) determination of relevant covariates beside study side,<br>h.) determination of resource and cost requirements for the intended multicenter study.<br>
- Secondary Outcome Measures
Name Time Method This includes generating experience regarding the goal and implementation (e.g., achieving and maintaining a difference between central and peripheral body temperature of <0.2 °C within 3 hours, and/or standardizing and measuring room temperature in terms of hot water bottles, heat packs, electric blankets, warm drinks, etc.) of equalizing central and peripheral body temperature as quickly as possible.