Newborn Complication, Newborn Morbidity
Conditions
Keywords
Newborn health, Newborn morbidity, Newborn critical care
Brief summary
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.
Interventions
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.
Sponsors
Center for Public Health and Development
Neopenda, PBC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a simple pre/post interventional study model.
Eligibility
Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
* Age \<28 days * Admitted to the neonatal intensive care unit * Weight at birth/admission ≥2000 g * Low-to-moderate disease severity as determined by the Signs of Inflammation in Children that Kill (SICK) score card (SICK score ≤2.4 at admission is eligible) * Parent/guardian willing to provide informed consent for their newborn to participate in study
Exclusion criteria
* Age \>28 days * Has a condition that impairs them from wearing the device, such as hydrocephaly. * Weight at birth \<2000 g * Very severe disease status (SICK score \>2.4 at admission)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital newborn mortality | From date of admission to date of discharge or referral or death, up to 28 days | Proportion of deaths that occur during hospital stay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | From date of admission to date of discharge or referral or death, up to 28 days | Proportion of cases that experience a complication resulting from their underlying illness or a complication resulting from their medical care. |
| Length of stay in hospital | From date of admission to date of discharge or referral or death, up to 28 days | Time elapsed between admission and discharge of a patient (measured in days). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean alarm-response time | From date of admission to date of discharge or referral or death, up to 28 days | 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). |
Countries
Kenya
Outcome results
None listed