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

Necrotizing Enterocolitis Clinical Trial

— BHAPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05544097
• Other study ID #: PI2019_843_0025
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2022
• Est. completion date: November 2025

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: André LOKOMBE-LEKE, DR
• Phone: 03 22 08 76 07
• Email: leke.andre[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 32 Weeks

Eligibility

Inclusion Criteria:

• preterm babies of less than 32WA

Exclusion Criteria:

• preterm babies of more than 32WA,

• digestive congenital malformation

Related Conditions & MeSH terms

• Amenorrhea
• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis
• Premature Birth
• Preterm Babies

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variation of spectral analysis of bowel sounds (frequency in Hz) before and after enteral nutrition	establishing spectral analysis of bowel sounds	36 months