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CALIFORNIA trial

Calprotectin, intestinal Fatty Acid Binding Protein, oral feeding, Near Infrared Spectroscopy and bile acids as possible prognostic factors for development of necrotising enterocolitis in high risk neonates

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22270
Enrollment
Unknown
Registered
2013-08-27
Start date
2012-10-05
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotising enterocolitis Near Infrared Spectroscopy (NIRS) Faecal microbiota Biomarkers Gut wall integrity Bile acids

Interventions

none

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children admitted to the neonatology department, which are - born at a gestational age of <30 weeks or - born with a birth weight of <1000 gram or - born at a gestational age of <32 weeks and categorized as small for gestational age (birth-weight ¡Ü 1200 gram) or - born with a cardiovascular disease resulting in a possibly reduced splanchnic bloodflow (e.g. aortic coarcation, heart disease with ductal dependent systemic circulation) or - antenatal exposed to NSAIDs (after maternal tocolysis with Indomethacine)

Exclusion criteria

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

Design outcomes

Secondary

MeasureTime frame
Urinary 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.

Primary

MeasureTime frame
The development of necrotising enterocolitis as determined by an independent paediatric radiologist (pneumatosis intestinalis on abdominal x-ray) or by surgeon during surgery

Contacts

Public ContactJBF Hulscher

Hanzeplein 1

+31 (0)50 3611735

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)