NCT05544097

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 6, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

3.2 years

First QC Date

September 6, 2022

Last Update Submit

July 9, 2024

Conditions

Bowel SoundsSpectral AnalysisNecrotizing EnterocolitisPreterm Babies

Keywords

bowel soundsspectral analysisNecrotizing Enterocolitispreterm babies

Outcome Measures

Primary Outcomes (1)

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

    establishing spectral analysis of bowel sounds

    36 months

Interventions

Recording of the bowel soundsOTHER

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

Eligibility Criteria

AgeUp to 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • preterm babies of less than 32WA

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80000, France

RECRUITING

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

André LOKOMBE-LEKE, DR

CONTACT

03 22 08 76 07leke.andre@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

September 16, 2022

Study Start

September 6, 2022

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

July 10, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)