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| Name | Class |
|---|---|
| Center for Public Health and Development | UNKNOWN |
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The neoGuard device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SpO2) in newborns. In this study, researchers will evaluate the feasibility of the neoGuard device at two rural health facilities in Western Kenya and assess the preliminary efficacy of the technology in improving health outcomes for newborns.
This is a pre/post intervention study. The standard-of-care arm (n=223) will be enrolled between 20 Oct - 20 Nov, 2020 and the neoGuard intervention arm (n=223) will be enrolled between 1 - 31 Dec, 2020.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard-of-care | No Intervention | The standard-of-care arm will receive intermittent monitoring of pulse rate and blood oxygen saturation with a conventional pulse oximeter. Temperature and respiratory rate will also be monitored intermittently with a digital thermometer and manual counting of breaths respectively. | |
| neoGuard vital signs monitor | Experimental | The intervention group will receive continuous vital signs monitoring of pulse rate, blood oxygen saturation, temperature and respiratory rate with the neoGuard device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoGuard vital signs monitor | Device | The neoGuardTM device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate, respiratory rate and blood oxygen saturation in newborns. |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital newborn mortality | Proportion of deaths that occur during hospital stay. | From date of admission to date of discharge or referral or death, up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Complication rate | Proportion of cases that experience a complication resulting from their underlying illness or a complication resulting from their medical care. | From date of admission to date of discharge or referral or death, up to 28 days |
| Length of stay in hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Mean alarm-response time | Average time elapsed between when each neoGuard alarm goes off and when a nurse attends to the patient (measured in seconds by the Neopenda app). | From date of admission to date of discharge or referral or death, up to 28 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Olayo, MD | Center for Public Health and Development | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kakamega County Referral Hospital | Kakamega | Kenya |
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This is a simple pre/post interventional study model.
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Time elapsed between admission and discharge of a patient (measured in days). |
| From date of admission to date of discharge or referral or death, up to 28 days |