Detection of Infant GastrointEstinal Activity Using Sound Technology

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-30
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

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 volunteers

Qualifiers

≥ 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year
2

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

Time frame
1 year

Secondary outcomes

Other outcomes

Locations

This trial has no 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: