Newborn Morbidity Clinical Trial
Official title:
Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya
Verified date | October 2020 |
Source | Neopenda, PBC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 167 |
Est. completion date | May 30, 2021 |
Est. primary completion date | May 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 28 Days |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Kenya | Kakamega County Referral Hospital | Kakamega |
Lead Sponsor | Collaborator |
---|---|
Neopenda, PBC | Center for Public Health and Development |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Length of stay in hospital | 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 |
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