Infant, Newborn, DiseasesDIGESTNCT07743216
Detection of Infant GastrointEstinal Activity Using Sound Technology
An observational study of Infant, Newborn, Diseases and Bowel Sounds, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
Trial summary
This pilot study aims to evaluate the feasibility and safety of continuous bowel sound monitoring in healthy term newborn infants using a novel wireless acoustic monitoring system. Read more about this study
- Who is it for?
- Ages 1 minute to 30 weeks
- Conditions the study is for
- Infant, Newborn, Diseases, Bowel Sounds, Physiologic Monitoring
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Dec 2027
- 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 1 minute to 30 weeks
- All sexes
- Child
Study population: Healthy term newborns in the postpartum unit.
Who may be able to join
- ≥ 37 weeks Gestational Age (GA)
Who cannot join
- Congenital anomalies
- Gastrointestinal abnormalities or disorders
- Low birth weight (< 2500 g)
- Maternal magnesium sulfate exposure prior to delivery*
- Fragile skin or skin conditions precluding sensor placement
About this study
This pilot study aims to evaluate the feasibility and safety of continuous bowel sound monitoring in healthy term newborn infants using a novel wireless acoustic monitoring system. Participants will undergo a single 4-hour recording during routine postnatal care while bowel sounds are continuously recorded using wearable abdominal sensors. Feasibility will be assessed by participant recruitment and study completion, as well as the acquisition of high-quality, analyzable acoustic data. Bowel sounds will be characterized by assessing the temporal and spectral features of bowel sounds during the early neonatal period and exploring their relationship with routine caregiving activities and feeding.
- Medical subject headings
- Infant, Newborn, Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of wireless acoustic monitoring of bowel sounds.
- Consent Rate: Proportion of families approached for study participation who provide informed consent.
- Recording Completion Rate: Proportion of enrolled infants who complete the planned 4-hour monitoring session.
- Usable Data Yield: Proportion of the total recording duration included in the final analysis after exclusion of segments unsuitable for bowel sound analysis due to motion artifact, environmental noise, or technical signal loss.
Measured: 1 year
Characteristics of bowel sounds
bowel sound frequency content, power spectral density, root mean square (RMS) signal amplitude, bowel sound occurrence over time, and their temporal relationship to feeding and other annotated clinical events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Newborn, DiseasesStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Querrey Simpson Institute for Bioelectronics (QSIB)
- Responsible party
- Principal investigator, Guilherme Sant'Anna, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743216
- Sponsor's protocol ID
- DIGEST
- Other IDs
- 2027-12864
- Acronym
- DIGEST
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Infant GastrointEstinal Activity Using Sound Technology
- ClinicalTrials.gov ID
- NCT07743216
- Acronym / sponsor ID
- DIGEST / DIGEST
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Northwestern Querrey Simpson Institute for Bioelectronics (QSIB)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 3 Aug 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.
This pilot study aims to evaluate the feasibility and safety of continuous bowel sound monitoring in healthy term newborn infants using a novel wireless acoustic monitoring system. Participants will undergo a single 4-hour recording during routine postnatal care while bowel sounds are continuously recorded using wearable abdominal sensors. Feasibility will be assessed by participant recruitment and study completion, as well as the acquisition of high-quality, analyzable acoustic data. Bowel sounds will be characterized by assessing the temporal and spectral features of bowel sounds during the early neonatal period and exploring their relationship with routine caregiving activities and feeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 minute to 30 weeks
- Sex
- All
- Age groups
- Child
- Study population
- Healthy term newborns in the postpartum unit.
Key inclusion criteria (1 listed)
- ≥ 37 weeks Gestational Age (GA)
Key exclusion criteria (5 listed)
- Congenital anomalies
- Gastrointestinal abnormalities or disorders
- Low birth weight (< 2500 g)
- Maternal magnesium sulfate exposure prior to delivery*
- Fragile skin or skin conditions precluding sensor placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of wireless acoustic monitoring of bowel sounds.
Time frame: 1 year
1. Consent Rate: Proportion of families approached for study participation who provide informed consent. 2. Recording Completion Rate: Proportion of enrolled infants who complete the planned 4-hour monitoring session. 3. Usable Data Yield: Proportion of the total recording duration included in the final analysis after exclusion of segments unsuitable for bowel sound analysis due to motion artifact, environmental noise, or technical signal loss.
Characteristics of bowel sounds
Time frame: 1 year
bowel sound frequency content, power spectral density, root mean square (RMS) signal amplitude, bowel sound occurrence over time, and their temporal relationship to feeding and other annotated clinical events
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 3 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Newborn, Diseases and Bowel Sounds, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of wireless acoustic monitoring of bowel sounds. (time frame: 1 year). The study lists 2 primary outcomes in all. 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 3 Aug 2026.