Detection of Infant GastrointEstinal Activity Using Sound Technology (DIGEST)
July 29, 2026 updated by: Guilherme Sant'Anna, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
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 Overview
Status
Not yet recruiting
Study Type
Observational
Enrollment (Estimated)
10
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Healthy term newborns in the postpartum unit.
Description
Inclusion Criteria:
- ≥ 37 weeks Gestational Age (GA)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of wireless acoustic monitoring of bowel sounds.
Time Frame: 1 year
|
|
1 year
|
|
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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
July 29, 2026
First Submitted That Met QC Criteria
July 29, 2026
First Posted (Actual)
August 3, 2026
Study Record Updates
Last Update Posted (Actual)
August 3, 2026
Last Update Submitted That Met QC Criteria
July 29, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIGEST
- 2027-12864 (Other Identifier: MUHC REB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.