Pediatric Oncology Patients With Risk for Infections
Conditions
Keywords
Fever, Neutropenia, Pediatric oncology, Core temperature, Wearable device, Continous monitoring, Automated alerts
Brief summary
In children and adolescents undergoing chemotherapy for cancer, fever in neutropenia (FN) is the most frequent potentially lethal complication of chemotherapy for cancer. Emergency hospitalization and empirical treatment with i.v. broad-spectrum antibiotics have reduced lethality from \>50% in certain high risk situations to \<1%. Fever without neutropenia is a further complication requiring emergency evaluation and often emergency treatment. Continuous monitoring of fever leads to earlier fever detection compared to the usual discrete fever measurements performed only for clinical reasons. Earlier detection of fever leads to earlier assessment and treatment and thus can reduce the risk of complications. This study primarily aims to assess, in pediatric patients undergoing chemotherapy for cancer, the efficacy of automated fever alerts resulting from continuous fever monitoring (CFM) using a wearable device (WD), measured by the duration of intravenous antibiotics (i.v. AB) given for any cause.
Detailed description
Primary objective The primary objective of this study is to determine if CFM fever alerts (CFM-FA) automatically sent by a WD reduce the duration of i.v. antibiotics application in children and adolescents treated with myelosuppressive chemotherapy for cancer. Secondary objectives Regarding safety A. Number of fever episodes (FE) with safety relevant events (SREs) B. Number of false alerts C. Number of missed alarms Regarding efficacy D. Delay of chemotherapy application E. Duration of antimicrobial application except i.v. antibiotics F. Number of FEs diagnosed below or at temperature limit (TL) versus above TL G. FEs according to chemotherapy intensity H. WD measured core temperature at time of fever detection by ear thermometer I. FEs reported outside TARs J. Quality of life Questionnaire K. Assessment of the side-effects of the WD Tertiary objective L. Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature M. Pattern search using data mining
Interventions
OTHERAutomated fever alerts
Fever alerts are automated sent to participants if fever is detected
Sponsors
ETH Zurich
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blinded
Intervention model description
Prospective interventional, multi-center, double-blinded, randomized controlled, multiple crossover superiority trial
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* Chemotherapy treatment because of any malignancy expected to last ≥2 months at time of recruitment for myelosuppressive therapy, or at least 1 cycle of myeloablative chemotherapy followed by hematopoietic stem cell transplantation * Age ≥1 month and \<18 years at time of recruitment * Written informed consent from patients and/or parents
Exclusion criteria
* Neonates \<1 months * Local skin disease prohibiting wearing of the WD * Denied written informed consent from patients and/or parents * Inclusion of vulnerable participants mandatory as vital signs and FN episodes differ significantly in children and adults
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective of this study is to determine if CFM fever alerts (CFM-FA) automatically sent by a WD reduce the duration of i.v. antibiotics application in children and adolescents treated with myelosuppressive chemotherapy for cancer. | 3 to 9 month per patient | The cumulative duration of i.v. antibiotics applied |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of false alerts | 3 to 9 month per patient | Number of false alerts |
| Number of missed alarms | 3 to 9 month per patient | Number of missed alarms |
| Number of fever episodes (FE) diagnosed below or at temperature limit (TL) versus above TL | 3 to 9 month per patient | Number of FEs diagnosed below or at TL versus above TL |
| Number of fever episodes (FE) with safety relevant events (SREs) | 3 to 9 month per patient | Number of FE with SREs |
| Delay of chemotherapy application | 3 to 9 month per patient | Duration of delay of chemotherapy application in days |
| FEs according to chemotherapy intensity | 3 to 9 month per patient | Amount of fever episodes according to chemotherapy intensity |
| Quality of life Questionnaire | Month 1, 6 and at study completion, an average of 1 year | Proportion of participants indicating that wearing a WDs is acceptable/unacceptable, not increasing anxiety/increasing anxiety, providing/not providing security, increase burden/effort or not |
| Assessment of the side-effects of the WD | Through study completion, an average of 1 year | Side effects reported by participants, if applicable |
| Duration of antimicrobial application except i.v. antibiotics | 3 to 9 month per patient | Duration of antimicrobial application except i.v. antibiotics |
| Wearable Device (WD) measured core temperature at time of fever detection by ear thermometer | 3 to 9 month per patient | WD measured core temperature at time of fever detection by ear thermometer |
| FEs reported outside times of risk (TARs) | 3 to 9 month per patient | Amount of fever episodes reported outside TARs |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of continuously recorded core temperature of the WD with results of discrete measurements of tympanic temperature | Through study completion, an average of 1 year | Difference between discrete measurements of core temperature |
| Vital sign pattern search in monitored core temperature using data mining | Through study completion, an average of 1 year | Exploration of potential changes in or specific patterns of all measured temperature signals within 48 hours before clinical diagnosis of fever |
Countries
Switzerland
Contacts
Primary ContactEva K Brack, MD, PhD
Backup ContactRoland Ammann, MD, Prof.
Outcome results
None listed