NIRS and Doppler to Predict NEC in Risk Neonates

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

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01833000

Acronym

NeoNIRS

Enrollment

Registered

2013-04-16

Start date

2013-02-01

Completion date

2016-03-01

Last updated

2026-06-15

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

Conditions

Necrotizing Enterolitis

Keywords

rectal bleeding, necrotizing enterolitis, splanchnic oxygenation, mesenteric doppler

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).

Interventions

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

ALL

Age

No minimum to 28 Days

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

Design outcomes

Primary

Measure	Time frame	Description
Cerebro-splanchnic oxygenation ratio	up to 48h	NIRS assessment

Secondary

Measure	Time frame
Mesenteric Doppler flow	up to 48h

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGilles Cambonie, MD,PhD

University Hospital, Montpellier

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026