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Not yet recruiting NCT07743216

Detection of Infant GastrointEstinal Activity Using Sound Technology

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Infant, Newborn, Diseases, Bowel Sounds, Physiologic Monitoring, Wearable Sensors. Basic parameters: 1 Minute — 30 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Feasibility of wireless acoustic monitoring of bowel sounds. [Time frame: 1 year]
  • Characteristics of bowel sounds [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07743216 · DIGEST · 2027-12864

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗