Bowel SoundsBHAPENCT05544097
Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis
A study testing Recording of the bowel sounds in people with Bowel Sounds and Spectral Analysis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Bowel Sounds, Spectral Analysis, Necrotizing Enterocolitis
- What is being tested?
- Recording of the bowel sounds
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2022to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm babies of less than 32WA
Who cannot join
- preterm babies of more than 32WA,
- digestive congenital malformation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80000
Andre Leke, MD, (33)322087607, leke.andre@chu-amiens.fr
Pierre TOURNEUX, Pr
About this study
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.
- Being tested
- Recording of the bowel sounds
- Keywords
- bowel sounds, spectral analysis, Necrotizing Enterocolitis, preterm babies
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording of the bowel soundsOther
Recording of the bowel sounds before and after enteral feeding three times a week with an electronical stethoscope
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of spectral analysis of bowel sounds (frequency in Hz) before and after enteral nutrition
establishing spectral analysis of bowel sounds
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start6 Sep 2022
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel SoundsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544097
- Sponsor's protocol ID
- PI2019_843_0025
- Acronym
- BHAPE
- Status last verified
- Jul 2024
- First submitted
- 6 Sep 2022
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral Analysis of Bowel Sounds in Preterm Babies of Less Than 32 Weeks of Amenorrhea (WA) as Predictive Factor of Enterocolitis
- ClinicalTrials.gov ID
- NCT05544097
- Acronym / sponsor ID
- BHAPE / PI2019_843_0025
- Keywords
- bowel sounds, spectral analysis, Necrotizing Enterocolitis, preterm babies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preterm babies of less than 32WA
Key exclusion criteria (2 listed)
- preterm babies of more than 32WA,
- digestive congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recording of the bowel soundsRecording of the bowel sounds before and after enteral feeding three times a week with an electronical stethoscope | Other | – |
Primary outcome
variation of spectral analysis of bowel sounds (frequency in Hz) before and after enteral nutrition
Time frame: 36 months
establishing spectral analysis of bowel sounds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recording of the bowel sounds in people with Bowel Sounds and Spectral Analysis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact André LOKOMBE-LEKE, DR (03 22 08 76 07, leke.andre@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of spectral analysis of bowel sounds (frequency in Hz) before and after enteral nutrition (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.