NIRS and Doppler to Predict NEC in Risk Neonates

Not Applicable

• Conditions: Necrotizing Enterolitis

• Registration Number: NCT01833000
• Lead Sponsor: University Hospital, Montpellier

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-04
• Study First Submitted: 2013-04-11
• Study First Submitted QC: 2013-04-11
• Last Update Submitted: 2013-04-11
• Study First Posted: 2013-04-16
• Last Update Posted: 2013-04-16
• Primary Completion: 2015-02
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cerebro-splanchnic oxygenation ratio	up to 48h	NIRS assessment

Secondary Outcome Measures

Name	Time	Method
Mesenteric Doppler flow	up to 48h

Trial Locations

Locations (1)

University Hospital of Montpellier; 🇫🇷 Montpellier, France