Monitoring vital signs of hospitalized newborns in Kenya using a wireless device
Evaluating the Clinical Impact and Cost-effectiveness of a Wireless Vital Sign Monitor for Hospitalized Newborns in Kenya
This study is testing a new wireless device to see if it can better monitor the vital signs of newborns in a Kenyan hospital compared to the usual methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | Neopenda, PBC Industry-sponsored |
| Locations | 1 site (Eldoret) |
| Trial ID | NCT05728307 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical impact and cost-effectiveness of the neoGuard wireless vital signs monitor for newborns at Moi Teaching and Referral Hospital in Kenya. It will compare the monitoring outcomes of newborns using neoGuard against those receiving standard-of-care monitoring. The study will assess the device's ability to detect vital sign changes, trigger timely nurse responses, and improve patient outcomes over a monitoring period of up to seven days. Additionally, user surveys will be conducted to gather feedback from medical staff on the device's feasibility and sustainability.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns admitted to specific subunits of the neonatal ward at Moi Teaching and Referral Hospital.
Not a fit: Patients with congenital anomalies incompatible with life, those receiving palliative care, or undergoing treatments that interfere with the neoGuard device will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and outcomes for hospitalized newborns, potentially reducing morbidity and mortality rates.
How similar studies have performed: While similar monitoring technologies have been explored, this specific application of the neoGuard device in a Kenyan neonatal setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Eldoret
- Moi Teaching and Referral Hospital — Eldoret, Kenya (Recruiting)
Study contacts
- Principal investigator: Festus Njuguna, MMed — Moi Teaching and Referral Hospital/Moi University
- Study coordinator: Assumpta S Nantume, MSc
- Email: assumpta@neopenda.com
- Phone: 2037472391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.