ClinicalTrials.gg
Not yet recruitingNCT07743216DIGESTUpdated Aug 3, 2026

Detection of Infant GastrointEstinal Activity Using Sound Technology

An observational study in Infant, Newborn, Diseases, Bowel Sounds and Physiologic Monitoring, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Not yet recruiting. Open to participants aged 1 Minute to 30 Weeks. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
1 Minute to 30 Weeks
Sex
All
01

Study 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.

02

Conditions studied

  • Infant, Newborn, Diseases
  • Bowel Sounds
  • Physiologic Monitoring
  • Wearable Sensors
03

In context

Infant, Newborn, Diseases

140 studies on the registry are indexed under Infant, Newborn, Diseases; 29 are open to participants now.

This study's planned enrollment of 10 is below the median of 100 across 49 observational studies indexed under Infant, Newborn, Diseases.

Browse Infant, Newborn, Diseases studies →

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 30 Weeks
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Healthy term newborns in the postpartum unit.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥ 37 weeks Gestational Age (GA)

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 32 observational studies under Infant, Newborn, Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 39. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2026
First posted
Aug 3, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Aug 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07743216
Collaborators
Northwestern Querrey Simpson Institute for Bioelectronics (QSIB)
Responsible party
Guilherme Sant'Anna, MD (Senior Clinician Scientist, Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Principal investigator
First posted
Aug 3, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Aug 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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