NIRS and Doppler to Predict NEC in Risk Neonates

Not Applicable

• Conditions: Necrotizing Enterolitis
• Interventions: Device: Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler

• 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

Arm && Interventions

Group	Intervention	Description
newborn suspected to suffer from necrotizing enterolitis	Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler	Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler

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