Post-market Observation of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya

Launched by ASSUMPTA SOLOME NANTUME · Feb 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new wireless device called the neoGuard that monitors vital signs in newborns who are hospitalized in Kenya. The main goal is to see if this device can effectively detect important changes in a newborn's health, help nurses respond quickly when a baby needs help, improve the overall health of the newborns, and determine if using neoGuard is cost-effective compared to standard monitoring methods. The trial will involve two groups: one group will use the neoGuard device, while the other group will receive the usual care.

To be eligible for the study, newborns must be admitted to specific units in the hospital and have a parent or guardian who agrees to use the neoGuard system. Newborns with certain serious health conditions or those receiving specific treatments will not be included in the trial. Participants will be monitored for up to seven days or until they leave the hospital. Families can expect regular updates on their baby's health during the study. This trial is important as it may lead to better monitoring practices and improved care for newborns in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Must be admitted to one of the subunits assigned to receive the intervention (i.e., APU category A or B, the HDU-1 or HDU-2)
• • The newborn's parent/guardian must provide informed consent to use the neoGuard system on their newborn.
• Exclusion Criteria:
• • Assessed to have congenital anomalies that are incompatible with life
• • Receiving palliative care
• • Patients undergoing phototherapy
• • Those with open head injuries/lacerations
• • Those receiving treatment that might interfere with application of the neoGuard device