About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 37 weeks Gestational Age (GA)
Disqualifiers
Congenital anomalies
Gastrointestinal abnormalities or disorders
Low birth weight (< 2500 g)
Maternal magnesium sulfate exposure prior to delivery*
Trial population
Healthy term newborns in the postpartum unit.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Feasibility of wireless acoustic monitoring of bowel sounds.
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
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
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead sponsor
Northwestern Querrey Simpson Institute for Bioelectronics (QSIB)
Collaborator
This trial is not recruiting at the moment. You can still explore other options: