Clinical trial Recruiting at 1 site Observational Ages 0 to 17

BreathAlert: a low-cost monitor to detect apnea in infants

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

Run by William Marsh Rice University · NCT07704320 · Data updated 2026-11-12

This study tests whether the BreathAlert device can reliably detect breathing and apnea events in infants compared with standard monitoring.

Quick facts

Study typeObservational
Ages0 Years to 17 Years
SexAll
Enrollment60 (estimated)
SponsorWilliam Marsh Rice University
Academic / other
Locations1 site (Blantyre)
StatusRecruiting
StartedMarch 11, 2017
Main results expectedDecember 2027
Study endsJune 2028
Registry record updatedNovember 6, 2026
Trial IDNCT07704320 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Infants in QECH's neonatal or pediatric wards who are at risk for apnea or require respiratory rate monitoring and whose caregivers consent to participation.

Probably not a fit

Infants whose apnea status is not related to respiratory rate monitoring or whose condition does not couple with BreathAlert readings may derive little or no benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers at Rice University, in collaboration with clinicians at Queen Elizabeth Central Hospital, are evaluating BreathAlert, a battery-powered, low-cost device that monitors respiratory rate and detects apneic episodes in infants. The study collects BreathAlert data alongside traditional vital signs to compare performance in identifying respiration and apnea events. The goal is to see if BreathAlert can match or improve upon conventional monitoring methods using simple, accessible technology. Participants are infants in QECH who require respiratory rate monitoring or are at risk for apnea, with informed consent provided by caregivers. The study is observational and focuses on device performance rather than therapeutic interventions.

Why it matters

Potential benefit: If successful, BreathAlert could provide a affordable, easy-to-use option for continuous apnea monitoring in infants.

How similar studies have gone: Previous research in similar respiratory-monitoring devices has shown promise, but direct validation for BreathAlert in this setting remains limited, making this study relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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:

Where it's running

  • Queen Elizabeth Central Hospital
    Blantyre, Malawi
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.