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RecruitingNCT05544097BHAPEUpdated Jul 10, 2024

Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis

An interventional study of Recording of the bowel sounds in Bowel Sounds, Spectral Analysis and Necrotizing Enterocolitis, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged Up to 32 Weeks. Per ClinicalTrials.gov, last updated 2024-07-10.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Nov 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Sep 2022; still recruiting 4 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
Up to 32 Weeks
Sex
All
01

Study summary

The recording or bowels is easy and cheap. The investigators wonder if these sounds are modified in babies with high risk of necrotizing enterocolitis. In this study, the investigators suggest to record and do a spectral analysis of 30 seconds of bowel sounds in preterm babies of less than 32WA before and after enteral nutrition, every day until the end of hospitalization. A spectral analysis will be made for each record to determine frequencies of the signal. The investigators will try to determine physiological frequencies and look for modifications in pathological situations.

02

Conditions studied

  • Bowel Sounds
  • Spectral Analysis
  • Necrotizing Enterocolitis
  • Preterm Babies

Keywords

  • bowel sounds
  • spectral analysis
  • Necrotizing Enterocolitis
  • preterm babies
03

In context

Enterocolitis, Necrotizing

228 studies on the registry are indexed under Enterocolitis, Necrotizing; 44 are open to participants now.

This study's planned enrollment of 50 is below the median of 103 across 127 interventional studies indexed under Enterocolitis, Necrotizing.

Browse Enterocolitis, Necrotizing studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

Browse Centre Hospitalier Universitaire, Amiens studies →

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

04

Who can participate

Ages eligible
Up to 32 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

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

  • preterm babies of less than 32WA

Exclusion criteria

Exclusion Criteria:

  • preterm babies of more than 32WA,
  • digestive congenital malformation
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Interventions

  • OtherRecording of the bowel sounds

    Recording of the bowel sounds before and after enteral feeding three times a week with an electronical stethoscope

06

What researchers measure

Primary outcomes

  1. variation of spectral analysis of bowel sounds (frequency in Hz) before and after enteral nutrition

    establishing spectral analysis of bowel sounds

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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

Started Sep 2022 (actual). Primary completion is estimated for Nov 2025, 38 months after the start.

Of 33 interventional studies with no phase under Enterocolitis, Necrotizing, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 59. This study's planned 38 months is close to that.

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

Registered
Sep 6, 2022
First posted
Sep 16, 2022
StartActual
Sep 6, 2022
Primary completionEst.
Nov 2025
CompletionEst.
Nov 2025
Last update
Jul 10, 2024
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 Jul 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05544097
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Sep 16, 2022
Start date
Sep 6, 2022
Primary completion
Nov 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Jul 10, 2024

Study contacts

André LOKOMBE-LEKE, DR
Contact
leke.andre@chu-amiens.fr
03 22 08 76 07

Oversight

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

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