Detection of Infant GastrointEstinal Activity Using Sound Technology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 10
- Primary Endpoint
- Feasibility of wireless acoustic monitoring of bowel sounds.
Study Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Minute to 30 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Guilherme Sant'Anna, MD
Senior Clinician Scientist, Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre