MedPath

CALIFORNIA trial

Recruiting
Conditions
ecrotising enterocolitisNear Infrared Spectroscopy (NIRS)Faecal microbiotaBiomarkersGut wall integrityBile acids
Registration Number
NL-OMON22270
Lead Sponsor
niversity Medical Center Groningen
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

All children admitted to the neonatology department, which are

- born at a gestational age of <30 weeks or

Exclusion Criteria

Other abdominal diseases, e.g. abdominal wall defects or congenital intestinal atresias

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The development of necrotising enterocolitis as determined by an independent paediatric radiologist (pneumatosis intestinalis on abdominal x-ray) or by surgeon during surgery
Secondary Outcome Measures
NameTimeMethod
rinary i-FABP/creatinin ratio, urinary 8-OHdG/creatinine ratio, urinary F2-IsoP/creatinin ratio, faecal Calprotectin and faecal bile acids, gene-expression (ao.TLR-4) on shedded enterocytes in the faeces, GLP1/2 in plasma, bile-acids in plasma, and regional tissue oxygenation measured by abdominal/cerebral NIRS.
© Copyright 2025. All Rights Reserved by MedPath