Pilot study ENEMO-Contactless Core Temperature Monitoring for the NIC
Completed
- Conditions
- n.v.t. het betreft temperatuur bewaking zonder indicatie van aandoeningen
- Registration Number
- NL-OMON37059
- Lead Sponsor
- Philips Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
Subjects will include neonates in the NICU and the medium care unit. The decision to include a neonate in the study will be made by Prof. dr. S. Bambang Oetomo in consultation with other clinicians at the MMC NICU. Subjects are premature infants born after a gestation of less than 34 weeks.
Exclusion Criteria
Neonates who are unstable or suffering from complications (major respiratory problems, low blood pressure, or severe infections) will be excluded from the study.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study parameter is to validate the temperature difference between<br /><br>the ZHF sensor and the temperature of the feedingtube. The difference has to be<br /><br>less than 0.2 degree. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Observing the function of the InnerSense feeding tube over time with respect<br /><br>to feeding periods, feeding quantity and feeding method.<br /><br><br /><br>2. Observing the change of temperature per neonate in context of the procedures<br /><br>performed and the health condition of the neonate.<br /><br><br /><br>3. What is the effect of the location of the ZHF sensors on the accuracy of<br /><br>temperature values measured? </p><br>