Necrotizing EnterocolitisECUN-2NCT04584320
Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Hospitalization
An observational study of Necrotizing Enterocolitis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control infants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- Stool sample
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2021to Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population consists of all newborns born less than 34 weeks of gestation admitted to the neonatology department of the CHU de Nîmes.
Who may be able to join
- Premature newborn with a term of birth ≤ 34 weeks of gestation admitted to the neonatology department at the CHU of Nîmes.
- Affiliated or beneficiary of a health insurance plan.
- Newborn whose parents received informed information about the study and did not express their opposition to their child's participation in the study.
Who cannot join
- Newborn with malformative digestive pathology
- Newborn baby participating in another category 1 trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative and Quantitative Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Their Hospitalization in Neonatology
The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control infants. Systematic daily samples should show that the kinetics of colonization precedes the onset of the pathology. Finally, the systematic ecological survey at the time of infection could help understand the mode of acquisition and transmission of these bacteria.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- Stool sample
- Keywords
- low-birth weight infant, Clostridium butyricum, Clostridium neonatale
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool sampleOther
Stools samples taken daily to test for present of Clostridium butyricum and Clostridium neonatale
| Study group | Role | What they receive |
|---|---|---|
| Premature neonates with necrotizing enterocolitis | Not described Receives: Other: Stool sample | |
| Premature neonates without necrotizing enterocolitis | Not described Receives: Other: Stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of C. butyricum
PCR
Measured: Each day of hospitalization (maximum 120 days)
Presence of C. neonatale
PCR
Measured: Each day of hospitalization (maximum 120 days)
Culture of C. butyricum
Growth on selective media
Measured: Each day of hospitalization (maximum 120 days)
Culture of C. neonatale
Growth on selective media
Measured: Each day of hospitalization (maximum 120 days)
Secondary outcomes (1)
Localisation within the hospital
Bed numbers occupied
Measured: During hospitalization (maximum 120 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start18 Oct 2021
- Primary completion9 Nov 2024
- Study completionOct 2025 (estimated)
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 Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo De Maio, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584320
- Sponsor's protocol ID
- NIMAO/2019-01/MdM01
- Acronym
- ECUN-2
- Status last verified
- Nov 2024
- First submitted
- 1 Oct 2020
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative and Quantitative Identification of Clostridium Butyricum and Clostridium Neonatal in the Digestive Microbiota of Premature Infants Before 34 Weeks and Developing or Not Ulcerative Necrotizing Enterocolitis (NEC) During Their Hospitalization in Neonatology
- ClinicalTrials.gov ID
- NCT04584320
- Acronym / sponsor ID
- ECUN-2 / NIMAO/2019-01/MdM01
- Conditions
- Necrotizing Enterocolitis
- Keywords
- low-birth weight infant, Clostridium butyricum, Clostridium neonatale
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 9 Nov 2024 (actual)
- Study completion
- Oct 2025 (estimated)
- First posted
- 12 Oct 2020 (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.
The study investigators hypothesize that Clostridium butyricum and Clostridium neonatal will be more frequently found in the stool of preterm infants with ulcerative necrotizing enterocolitis compared to healthy matched control infants. Systematic daily samples should show that the kinetics of colonization precedes the onset of the pathology. Finally, the systematic ecological survey at the time of infection could help understand the mode of acquisition and transmission of these bacteria.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premature neonates with necrotizing enterocolitis | – | Other: Stool sample |
| Premature neonates without necrotizing enterocolitis | – | Other: Stool sample |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of all newborns born less than 34 weeks of gestation admitted to the neonatology department of the CHU de Nîmes.
Key inclusion criteria (3 listed)
- Premature newborn with a term of birth ≤ 34 weeks of gestation admitted to the neonatology department at the CHU of Nîmes.
- Affiliated or beneficiary of a health insurance plan.
- Newborn whose parents received informed information about the study and did not express their opposition to their child's participation in the study.
Key exclusion criteria (2 listed)
- Newborn with malformative digestive pathology
- Newborn baby participating in another category 1 trial
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 |
|---|---|---|
| Stool sampleStools samples taken daily to test for present of Clostridium butyricum and Clostridium neonatale | Other | Premature neonates with necrotizing enterocolitis, Premature neonates without necrotizing enterocolitis |
Primary outcome
Presence of C. butyricum
Time frame: Each day of hospitalization (maximum 120 days)
PCR
Presence of C. neonatale
Time frame: Each day of hospitalization (maximum 120 days)
PCR
Culture of C. butyricum
Time frame: Each day of hospitalization (maximum 120 days)
Growth on selective media
Culture of C. neonatale
Time frame: Each day of hospitalization (maximum 120 days)
Growth on selective media
1 secondary outcome
Localisation within the hospital
Time frame: During hospitalization (maximum 120 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
Related trials for Necrotizing Enterocolitis
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Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
Active, not recruitingObservational study
Early Predictors of Necrotizing Enterocolitis in Neonates
Necrotizing Enterocolitis
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
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.
Massimo De Maio principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Enterocolitis, run by Centre Hospitalier Universitaire de Nīmes 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 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: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Presence of C. butyricum (time frame: Each day of hospitalization (maximum 120 days)). The study lists 4 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 14 Nov 2024.