Apnea InfantNCT07704320
Clinical Assessment of the BreathAlert Device in Monitoring Apneic Episodes
An observational study of Apnea Infant, run by William Marsh Rice University at 1 site in Malawi.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Apnea Infant
- What is being tested?
- BreathAlert (low cost respiratory rate and apnea monitor)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteMalawi
- Study dates
- 11 Mar 2017to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients in the neonatal or pediatric ward deemed to be at risk for apnea or in need of respiratory rate monitoring
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malawi1 site, 1 recruiting
- Recruiting
Queen Elizabeth Central Hospital
Blantyre
Rebecca Richards-Kortum, PhD, 7133483823, rkortum@rice.edu
Queen Dube, MD, drdubefirst@yahoo.com
About this study
Official title: 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.
- Conditions
- Apnea Infant
- Being tested
- BreathAlert (low cost respiratory rate and apnea monitor)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreathAlert (low cost respiratory rate and apnea monitor)Device
A BreathAlert device is attached to the subject. Data from BreathAlert and vital signs monitors is collected.
| Study group | Role | What they receive |
|---|---|---|
| Patients in the neonatal/pediatric ward at risk for apnea or in need of respiratory rate monitoring | Not described Receives: Device: BreathAlert (low cost respiratory rate and apnea monitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of BreathAlert
Accuracy of BreathAlert respiratory rate measurement compared to visual counting and standard patient monitors
Measured: Maximum of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start11 Mar 2017
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- William Marsh Rice University
- Sponsor type
- University, hospital or other
- Collaborators
- Kamuzu University of Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704320
- Sponsor's protocol ID
- 2026-101
- Status last verified
- Nov 2026
- First submitted
- 9 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Assessment of the BreathAlert Device in Monitoring Apneic Episodes in Infants at Risk for Apnea
- ClinicalTrials.gov ID
- NCT07704320
- Acronym / sponsor ID
- 2026-101
- Conditions
- Apnea Infant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- William Marsh Rice UniversityUniversity, hospital or other
- Collaborators
- Kamuzu University of Health Sciences
- Study start
- 11 Mar 2017 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients in the neonatal or pediatric ward deemed to be at risk for apnea or in need of respiratory rate monitoring
Key inclusion criteria (5 listed)
- Participants will be identified using the eligibility criteria stipulated below.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Patients in the neonatal/pediatric ward at risk for apnea or in need of respiratory rate monitoring |
Primary outcome
Accuracy of BreathAlert
Time frame: Maximum of one week
Accuracy of BreathAlert respiratory rate measurement compared to visual counting and standard patient monitors
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea Infant, run by William Marsh Rice University at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Plante (17133484167, jcarns@rice.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of BreathAlert (time frame: Maximum of one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.