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Clinical Trials/NCT01833000
NCT01833000
Unknown
Not Applicable

Assessment of Splanchnic Oxygenation and Circulation in Neonates at Risk for Necrotizing Enterocolitis Using NIRS and Doppler

University Hospital, Montpellier1 site in 1 country69 target enrollmentFebruary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Necrotizing Enterolitis
Sponsor
University Hospital, Montpellier
Enrollment
69
Locations
1
Primary Endpoint
Cerebro-splanchnic oxygenation ratio
Last Updated
13 years ago

Overview

Brief Summary

The main objective is to evaluate the interest of cerebro-splanchnic oxygenation ratio (CSOR) for early diagnosis of necrotizing enterocolitis (NEC) in neonates with rectal bleeding and/or abdominal distension. CSOR will be determined using near infrared spectroscopy (NIRS).

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
February 2015
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • less than 28 days neonates hospitalised in neonatology care unit presenting rectal bledding and/or abdominal distension
  • signed authorization by the parents (consent form)

Exclusion Criteria

  • - cutaneous lesions in the regions of monitoring
  • emergency for NEC

Outcomes

Primary Outcomes

Cerebro-splanchnic oxygenation ratio

Time Frame: up to 48h

NIRS assessment

Secondary Outcomes

  • Mesenteric Doppler flow(up to 48h)

Study Sites (1)

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