Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya
Primary Purpose
Newborn Morbidity, Newborn Complication
Status
Completed
Phase
Early Phase 1
Locations
Kenya
Study Type
Interventional
Intervention
neoGuard vital signs monitor
Sponsored by
About this trial
This is an interventional supportive care trial for Newborn Morbidity focused on measuring Newborn health, Newborn morbidity, Newborn critical care
Eligibility Criteria
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)
Sites / Locations
- Kakamega County Referral Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard-of-care
neoGuard vital signs monitor
Arm Description
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.
The intervention group will receive continuous vital signs monitoring of pulse rate, blood oxygen saturation, temperature and respiratory rate with the neoGuard device.
Outcomes
Primary Outcome Measures
In-hospital newborn mortality
Proportion of deaths that occur during hospital stay.
Secondary Outcome Measures
Complication rate
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
Time elapsed between admission and discharge of a patient (measured in days).
Full Information
NCT ID
NCT04606589
First Posted
October 14, 2020
Last Updated
March 21, 2023
Sponsor
Neopenda, PBC
Collaborators
Center for Public Health and Development
1. Study Identification
Unique Protocol Identification Number
NCT04606589
Brief Title
Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya
Official Title
Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neopenda, PBC
Collaborators
Center for Public Health and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newborn Morbidity, Newborn Complication
Keywords
Newborn health, Newborn morbidity, Newborn critical care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
This is a simple pre/post interventional study model.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard-of-care
Arm Type
No Intervention
Arm Description
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.
Arm Title
neoGuard vital signs monitor
Arm Type
Experimental
Arm Description
The intervention group will receive continuous vital signs monitoring of pulse rate, blood oxygen saturation, temperature and respiratory rate with the neoGuard device.
Intervention Type
Device
Intervention Name(s)
neoGuard vital signs monitor
Intervention Description
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.
Primary Outcome Measure Information:
Title
In-hospital newborn mortality
Description
Proportion of deaths that occur during hospital stay.
Time Frame
From date of admission to date of discharge or referral or death, up to 28 days
Secondary Outcome Measure Information:
Title
Complication rate
Description
Proportion of cases that experience a complication resulting from their underlying illness or a complication resulting from their medical care.
Time Frame
From date of admission to date of discharge or referral or death, up to 28 days
Title
Length of stay in hospital
Description
Time elapsed between admission and discharge of a patient (measured in days).
Time Frame
From date of admission to date of discharge or referral or death, up to 28 days
Other Pre-specified Outcome Measures:
Title
Mean alarm-response time
Description
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).
Time Frame
From date of admission to date of discharge or referral or death, up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Olayo, MD
Organizational Affiliation
Center for Public Health and Development
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kakamega County Referral Hospital
City
Kakamega
Country
Kenya
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya
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