Clinical Assessment of the BreathAlert Device in Monitoring Apneic Episodes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BreathAlert (low cost respiratory rate and apnea monitor).
- Who it may be relevant to
- Registry conditions: Apnea Infant. Basic parameters: 0 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malawi
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Clinical Assessment of the BreathAlert Device in Monitoring Apneic Episodes in Infants at Risk for Apnea
Overview
A team of researchers at Rice University in partnership with clinicians at Queen Elizabeth Central Hospital created BreathAlert, a low cost battery-powered monitor that detects and corrects apnea. This study evaluates the ability of BreathAlert to detect respiration and apneic episodes in infants. Data from BreathAlert and vital signs monitors is collected. The performance of BreathAlert in respiration and apnea detection is compared with traditional vital sign monitoring which may include temperature, heart rate, EKG, respiratory rate, SPO2 and impedance pneumography.
Interventions
- Device BreathAlert (low cost respiratory rate and apnea monitor)
A BreathAlert device is attached to the subject. Data from BreathAlert and vital signs monitors is collected.
Primary outcome measures
- Accuracy of BreathAlert [Time frame: Maximum of one week]
Eligibility criteria
Inclusion criteria
- Participants will be identified using the eligibility criteria stipulated below.
- The patient is currently being treated at QECH in the neonatal or pediatric ward.
- The patient is deemed to be at risk for apnea or in need of respiratory rate monitoring.
- A BreathAlert device is available for use while the patient is at risk for apnea.
- The patient's caregiver has provided informed consent for their child to participate.
Exclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Malawi · 1 center
- Queen Elizabeth Central Hospital — Blantyre
Identifiers
NCT: NCT07704320 · 2026-101