Detection of Infant GastrointEstinal Activity Using Sound Technology

NCT07743216 | Not Yet Recruiting

• 2 other identifiers: DIGEST2027-12864
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infant, Newborn, Diseases; Bowel Sounds; Physiologic Monitoring; Wearable Sensors

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  1 year

Eligibility Criteria

• Age: 1 Minute - 30 Weeks
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy term newborns in the postpartum unit.

You may qualify if:

• ≥ 37 weeks Gestational Age (GA)

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern Querrey Simpson Institute for Bioelectronics (QSIB): collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinician Scientist, Professor

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07