Detection of Infant GastrointEstinal Activity Using Sound Technology

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07743216

Acronym

DIGEST

Enrollment

Registered

2026-08-03

Start date

2026-09-01

Completion date

2027-12-01

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 30 Weeks

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

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of wireless acoustic monitoring of bowel sounds.	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	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

Outcome results