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Pilot study ENEMO-Contactless Core Temperature Monitoring for the NICU

Pilot study ENEMO-Contactless Core Temperature Monitoring for the NICU - Pilot study Core temperature NICU

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37059
Enrollment
16
Registered
2012-10-31
Start date
2012-11-26
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

n.v.t. het betreft temperatuur bewaking zonder indicatie van aandoeningen n.v.t. het betreft temperatuur bewaking zonder indicatie van aandoeningen

Interventions

None listed

Sponsors

Philips Research
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The primary study parameter is to validate the temperature difference between the ZHF sensor and the temperature of the feedingtube. The difference has to be less than 0.2 degree.

Secondary

MeasureTime frame
1. Observing the function of the InnerSense feeding tube over time with respect to feeding periods, feeding quantity and feeding method. 2. Observing the change of temperature per neonate in context of the procedures performed and the health condition of the neonate. 3. What is the effect of the location of the ZHF sensors on the accuracy of temperature values measured?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)