Necrotizing EnterolitisNeoNIRSNCT01833000
NIRS and Doppler to Predict NEC in Risk Neonates
A study testing Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler in people with Necrotizing Enterolitis, run by University Hospital, Montpellier at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Necrotizing Enterolitis
- What is being tested?
- Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to 1 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- less than 28 days neonates hospitalised in neonatology care unit presenting rectal bledding and/or abdominal distension
- signed authorization by the parents (consent form)
Who cannot join
- - cutaneous lesions in the regions of monitoring
- emergency for NEC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Splanchnic Oxygenation and Circulation in Neonates at Risk for Necrotizing Enterocolitis Using NIRS and Doppler
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).
- Conditions
- Necrotizing Enterolitis
- Being tested
- Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler
- Keywords
- rectal bleeding, necrotizing enterolitis, splanchnic oxygenation, mesenteric doppler
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric DopplerDevice
| Study group | Role | What they receive |
|---|---|---|
| newborn suspected to suffer from necrotizing enterolitis | Other | Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler Receives: Device: Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebro-splanchnic oxygenation ratio
NIRS assessment
Measured: up to 48h
Secondary outcomes (1)
Mesenteric Doppler flow
Measured: up to 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completion1 Mar 2016
- Study completion1 Mar 2016
Why it stopped: No prolongation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Necrotizing EnterolitisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Cambonie, MD,PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833000
- Sponsor's protocol ID
- 9048
- Acronym
- NeoNIRS
- Status last verified
- May 2026
- First submitted
- 11 Apr 2013
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Le Bouhellec J, Prodhomme O, Mura T, Jacquot A, Combes C, Gamon L, Durand S, Filleron A, Cambonie G. Near-Infrared Spectroscopy: A Tool for Diagnosing Necrotizing Enterocolitis at Onset of Symptoms in Preterm Neonates with Acute Gastrointestinal Symptoms? Am J Perinatol. 2021 Aug;38(S 01):e299-e308. doi: 10.1055/s-0040-1710033. Epub 2020 Apr 23.
PubMed 32325507
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Splanchnic Oxygenation and Circulation in Neonates at Risk for Necrotizing Enterocolitis Using NIRS and Doppler
- ClinicalTrials.gov ID
- NCT01833000
- Acronym / sponsor ID
- NeoNIRS / 9048
- Conditions
- Necrotizing Enterolitis
- Keywords
- rectal bleeding, necrotizing enterolitis, splanchnic oxygenation, mesenteric doppler
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No prolongation
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| newborn suspected to suffer from necrotizing enterolitis | Other | Device: Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric DopplerCerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- less than 28 days neonates hospitalised in neonatology care unit presenting rectal bledding and/or abdominal distension
- signed authorization by the parents (consent form)
Key exclusion criteria (2 listed)
- - cutaneous lesions in the regions of monitoring
- emergency for NEC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler | Device | newborn suspected to suffer from necrotizing enterolitis |
Primary outcome
Cerebro-splanchnic oxygenation ratio
Time frame: up to 48h
NIRS assessment
1 secondary outcome
Mesenteric Doppler flow
Time frame: up to 48h
Results and safety
The study was stopped early (reason given: No prolongation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Results publication: PubMed 32325507Le Bouhellec J, Prodhomme O, Mura T, Jacquot A, Combes C, Gamon L, Durand S, Filleron A, Cambonie G. Near-Infrared Spectroscopy: A Tool for Diagnosing Necrotizing Enterocolitis at Onset of Symptoms in Preterm Neonates with Acute Gastrointestinal Symptoms? Am J Perinatol. 2021 Aug;38(S 01):e299-e308. doi: 10.1055/s-0040-1710033. Epub 2020 Apr 23.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Cambonie, MD,PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler in people with Necrotizing Enterolitis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No prolongation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebro-splanchnic oxygenation ratio (time frame: up to 48h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01833000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.