Clinical Assessment of the BreathAlert Device in Monitoring Apneic Episodes

Pilot Clinical Assessment of the BreathAlert Device in Monitoring Apneic Episodes in Infants at Risk for Apnea

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.

Study Overview

• Status: Recruiting
• Conditions: Apnea Infant
• Intervention / Treatment: Device: BreathAlert (low cost respiratory rate and apnea monitor)

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Jennifer Plante; Phone Number: 17133484167; Email: jcarns@rice.edu

Study Locations

• Malawi
  • Blantyre, Malawi
    • Recruiting
    • Queen Elizabeth Central Hospital
    • Contact: Queen Dube, MD; Email: drdubefirst@yahoo.com
    • Contact: Rebecca Richards-Kortum, PhD; Phone Number: 7133483823; Email: rkortum@rice.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in the neonatal or pediatric ward deemed to be at risk for apnea or in need of respiratory rate monitoring

Description

Inclusion Criteria:

• Participants will be identified using the eligibility criteria stipulated below.

  1. The patient is currently being treated at QECH in the neonatal or pediatric ward.
  2. The patient is deemed to be at risk for apnea or in need of respiratory rate monitoring.
  3. A BreathAlert device is available for use while the patient is at risk for apnea.

  4. The patient's caregiver has provided informed consent for their child to participate.

     Exclusion Criteria:

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients in the neonatal/pediatric ward at risk for apnea or in need of respiratory rate monitoring	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Accuracy of BreathAlert	Maximum of one week

Collaborators and Investigators

• Sponsor: William Marsh Rice University
• Collaborators: Kamuzu University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2017
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No