NIRS and Doppler to Predict NEC in Risk Neonates (NeoNIRS)

University Hospital Center (CHU)

Status: Unknown

Conditions: Necrotizing Enterolitis

Treatments: Device: Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler

Study type: Interventional

Funder types: Other

Identifiers

NCT01833000

9048 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 69 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

newborn suspected to suffer from necrotizing enterolitis

Other group

Description:

Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler

Treatment:

Device: Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler