Necrotizing EnterocolitisCortECSNCT04972734
Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants
A study testing premature newborns developing a NEC and premature newborns without NEC in people with Necrotizing Enterocolitis and Premature Birth, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Compare the bacterial digestive microbiota during the stay in neonatal intensive care between a group of premature newborns developing a NEC (necrotizing enterocolitis) and a group of newborns free from NEC. Read more about this study
- Who is it for?
- Ages 1 minute to 2 minutes
- Conditions the study is for
- Necrotizing Enterocolitis, Premature Birth
- What is being tested?
- premature newborns developing a NEC and premature newborns without NEC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 297 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2021to 1 Aug 2024
- 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 1 minute to 2 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- born prematurely < 37 weeks of amenorrhea at the maternity ward of the CHU
- affiliated with a social security regime
- the holders of parental authority are able to give an informed consent to participate in the research
Who cannot join
- fetal pathology
- newborns whose holders of parental authority are under guardianship or under the age of 18
- refusal of participation by holders of parental authority
Trial locations and contacts
1 site in 1 country.
About this study
Compare the bacterial digestive microbiota during the stay in neonatal intensive care between a group of premature newborns developing a NEC (necrotizing enterocolitis) and a group of newborns free from NEC.
Read the detailed description
Monitoring of a cohort of premature newborns with constitution of a collection of biological samples.
follow-up of newborns from birth up to 37 weeks of amenorrhea. The medical care of children will not be affected by their participation in the research.
- Sampling of amniotic fluid at the time of rupture of the water bag
- Sampling of the blood contained in the umbilical cord after clamping and section of the cord
- Sampling of meconium during the first 24 hours of life in intensive care / neonatal / maternity ward
- Collection of a daily stool sample until the end of hospitalization and when a NEC occurs
- Sampling of gastric residues during an episode of NEC
- Taking a daily sample of the newborn's enteral food
- Sampling of 500 µL of additional blood weekly during the punctures made for the treatment
- Daily statement of constants
- Record of all complications related to prematurity (HIV, bronchodysplastic, sepsis)
- Blood analysis: CBC, platelets and CRP (data analyzed as part of the treatment). Specific analyzes for research will assess: the level of tryptase, IL4 and TLR4. The samples will be stored and analyzed in the immunology laboratory of the CHU Clermont Ferrand (Pr B. Evrard)
- Analysis of the meconium sample and each stool emitted during hospitalization, and during an episode of ECUN
- Conditions
- Necrotizing Enterocolitis, Premature Birth
- Being tested
- premature newborns developing a NEC, premature newborns without NEC
- Keywords
- Necrotizing Enterocolitis, prematurity, volatolomic and microbiological signatures, mast cell activation, blood tryptase assay, fungal digestive colonization, fecal calprotectin
- Medical subject headings
- Enterocolitis, Necrotizing, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
premature newborns developing a NECBiological
weekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC
premature newborns without NECBiological
weekly Blood sample and daily Stools sample during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| NEC | Experimental | premature newborns developing a NEC Receives: Biological: premature newborns developing a NEC |
| Healthy control | Active comparator | premature newborns without NEC Receives: Biological: premature newborns without NEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of volatolomics results of the gut microbiota
Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA
Measured: Immediatly after the intervention
comparison of microbiological results of the gut microbiota
Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA
Measured: Immediatly after the intervention
Secondary outcomes (5)
Fungal microbiota
Comparison of the fungal microbiota on 10 NECS and 10 healthy babies
Measured: Immediatly after the intervention
Tryptasemia
measurement of blood tryptasemia
Measured: Day 1, Day 3, Immediatly after the intervention
environmental xenobiotics
measurement of titane and silicia levels in placental and meconium assays
Measured: Day 1
Milk protein composition
milk protein determination
Measured: daily for 12 weekd
Milk lipid composition
milk lipid determination
Measured: daily for 12 weekd
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start2 Jul 2021
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 297 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- MEDIS Laboratory, QUAPA, ENTeRisk
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972734
- Sponsor's protocol ID
- RBHP 2021 PONS
- Acronym
- CortECS
- Status last verified
- Sep 2026
- First submitted
- 28 Jun 2021
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Premature Newborns for Charaterization of the Digestive Microbiota in Ulcerative Necrotizing Enterocolitis in Premature Infants
- ClinicalTrials.gov ID
- NCT04972734
- Acronym / sponsor ID
- CortECS / RBHP 2021 PONS
- Conditions
- Necrotizing Enterocolitis, Premature Birth
- Keywords
- Necrotizing Enterocolitis, prematurity, volatolomic and microbiological signatures, mast cell activation, blood tryptase assay, fungal digestive colonization, fecal calprotectin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 297 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- MEDIS Laboratory, QUAPA, ENTeRisk
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 22 Jul 2021 (actual)
- 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.
Compare the bacterial digestive microbiota during the stay in neonatal intensive care between a group of premature newborns developing a NEC (necrotizing enterocolitis) and a group of newborns free from NEC.
Detailed description
Monitoring of a cohort of premature newborns with constitution of a collection of biological samples.
follow-up of newborns from birth up to 37 weeks of amenorrhea. The medical care of children will not be affected by their participation in the research.
- Sampling of amniotic fluid at the time of rupture of the water bag
- Sampling of the blood contained in the umbilical cord after clamping and section of the cord
- Sampling of meconium during the first 24 hours of life in intensive care / neonatal / maternity ward
- Collection of a daily stool sample until the end of hospitalization and when a NEC occurs
- Sampling of gastric residues during an episode of NEC
- Taking a daily sample of the newborn's enteral food
- Sampling of 500 µL of additional blood weekly during the punctures made for the treatment
- Daily statement of constants
- Record of all complications related to prematurity (HIV, bronchodysplastic, sepsis)
- Blood analysis: CBC, platelets and CRP (data analyzed as part of the treatment). Specific analyzes for research will assess: the level of tryptase, IL4 and TLR4. The samples will be stored and analyzed in the immunology laboratory of the CHU Clermont Ferrand (Pr B. Evrard)
- Analysis of the meconium sample and each stool emitted during hospitalization, and during an episode of ECUN
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NEC | Experimental | Biological: premature newborns developing a NECpremature newborns developing a NEC |
| Healthy control | Active comparator | Biological: premature newborns without NECpremature newborns without NEC |
Who may qualify
- Ages
- 1 minute to 2 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- born prematurely < 37 weeks of amenorrhea at the maternity ward of the CHU
- affiliated with a social security regime
- the holders of parental authority are able to give an informed consent to participate in the research
Key exclusion criteria (3 listed)
- fetal pathology
- newborns whose holders of parental authority are under guardianship or under the age of 18
- refusal of participation by holders of parental authority
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 |
|---|---|---|
| premature newborns developing a NECweekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC | Biological | NEC |
| premature newborns without NECweekly Blood sample and daily Stools sample during 12 weeks | Biological | Healthy control |
Primary outcome
comparison of volatolomics results of the gut microbiota
Time frame: Immediatly after the intervention
Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA
comparison of microbiological results of the gut microbiota
Time frame: Immediatly after the intervention
Characterization of the gut microbiota using a capture method by hybridization of the gene encoding 16S rRNA
5 secondary outcomes
Fungal microbiota
Time frame: Immediatly after the intervention
Tryptasemia
Time frame: Day 1, Day 3, Immediatly after the intervention
environmental xenobiotics
Time frame: Day 1
Milk protein composition
Time frame: daily for 12 weekd
Milk lipid composition
Time frame: daily for 12 weekd
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing premature newborns developing a NEC and premature newborns without NEC in people with Necrotizing Enterocolitis and Premature Birth, run by University Hospital, Clermont-Ferrand 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 10 Sep 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
comparison of volatolomics results of the gut microbiota (time frame: Immediatly after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.