NeoNIRS: NIRS and Doppler to Predict NEC in Risk Neonates
Sponsor
University Hospital, Montpellier (Other)
Overall Status
Unknown status
CT.gov ID
NCT01833000
Collaborator
(none)
69
1
1
24
2.9
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
69 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Assessment of Splanchnic Oxygenation and Circulation in Neonates at Risk for Necrotizing Enterocolitis Using NIRS and Doppler
Study Start Date
:
Feb 1, 2013
Anticipated Primary Completion Date
:
Feb 1, 2015
Anticipated Study Completion Date
:
Feb 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: newborn suspected to suffer from necrotizing enterolitis Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler |
Device: Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler
|
Outcome Measures
Primary Outcome Measures
- Cerebro-splanchnic oxygenation ratio [up to 48h]
NIRS assessment
Secondary Outcome Measures
- Mesenteric Doppler flow [up to 48h]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 28 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital of Montpellier | Montpellier | France | 34295 |
Sponsors and Collaborators
- University Hospital, Montpellier
Investigators
- Principal Investigator: Gilles Cambonie, MD,PhD, University Hospital, Montpellier
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01833000
Other Study ID Numbers:
- 9048
First Posted:
Apr 16, 2013
Last Update Posted:
Apr 16, 2013
Last Verified:
Apr 1, 2013
Keywords provided by University Hospital, Montpellier