Necrotizing Enterocolitis of NewbornNCT05619055
The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis
An observational study of Necrotizing Enterocolitis of Newborn, run by Zuohui Zhao at 1 site in China.
Trial summary
Study Description The goal of this observational study is to detect intestinal flora and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. The main questions it aims to answer are: 1. Whether there is intestinal flora in the stool of premature infants. 2. Read more about this study
- Who is it for?
- Ages 5 days to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Necrotizing Enterocolitis of Newborn
- What is being tested?
- Routine treatment
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2022to 31 Mar 2025
- Phase
- Observational
- 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 5 days to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Hospitalized children in Neonatology
Who may be able to join
- clinical diagnosis of Necrotizing Enterocolitis,
- gestational age <37 weeks,
- body weight 1,000-2,500 g,
- postnatal Apgar score ≥7,
- initial oral feeding tolerance.
Who cannot join
- serious hereditary or other serious diseases, such as heart, lung and abdominal malformations ,
- early or late onset septicemia,
- early use of antibiotics in the newborn,
- serious adverse reactions caused by probiotics.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong
Wenjiao Jiao, 0086-531-89269891, qykyc309@163.com
Zuohui Zhao, Dr
About this study
Official title: The Role and Mechanism of Intestinal Dysbacteriosis Impairing the Intestinal Mucosal Barrier in the Pathogenesis of Necrotizing Enterocolitis in Premature Infants
Study Description
The goal of this observational study is to detect intestinal flora and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. The main questions it aims to answer are:
Read more
- 1. Whether there is intestinal flora in the stool of premature infants.
- 2. Are there dysregulated intestinal flora and their metabolic products in premature infants diagnosed as necrotizing enterocolitis.
- 3. The detailed role and underlying mechanism of the intestinal dysbacteriosis and the metabolic products in premature infants diagnosed as necrotizing enterocolitis.
Participants, premature infants diagnosed as necrotizing enterocolitis (NEC group), will be asked to collect stool (usually 2 times) for intestinal flora analysis.
If there is a comparison group: Researchers will compare premature infants without necrotizing enterocolitis (control group) to see if their intestinal flora and the metabolic products also changed as their NEC counterparts.
Read the detailed description
When the patients is hospitalized in neonatology, we screen the premature infants according to the selection criteria and exclusion criteria. After sighed the informed consent, they are classified into two groups: premature infants diagnosed as necrotizing enterocolitis (NEC group) and premature infants without necrotizing enterocolitis (control group). Their stool and blood (usually 2 times ) are collected for intestinal flora and FABP (including L-FABP and I-FABP) analysis, respectively.
- Conditions
- Necrotizing Enterocolitis of Newborn
- Being tested
- Routine treatment
- Keywords
- Necrotizing Enterocolitis, intestinal flora
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine treatmentOther
Antibiotics, intravenous fluids and symptomatic supportive treatment.
| Study group | Role | What they receive |
|---|---|---|
| neonate with necrotizing enterocolitis | premature infants diagnosed as necrotizing enterocolitis Receives: Other: Routine treatment | |
| neonate without necrotizing enterocolitis | premature infants without necrotizing enterocolitis Receives: Other: Routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
intestinal flora
the intestinal flora in the stool using 16S ribosomal RNA(rRNA) gene sequencing
Measured: up to 4 weeks
short-chain fatty acids
short-chain fatty acids, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing
Measured: up to 4 weeks
neurotransmitters
neurotransmitters, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing
Measured: up to 4 weeks
lipopolysaccharide
lipopolysaccharide, a metabolic product of intestinal flora, in the stool using 16S rRNA gene sequencing
Measured: up to 4 weeks
L-FABP
L-FABP, the injury marker of intestinal mucosa, in the blood
Measured: up to 4 weeks
I-FABP
I-FABP, the injury marker of intestinal mucosa, in the blood
Measured: up to 4 weeks
hospital stay
one vital clinical outcome of the premature infants
Measured: up to 4 weeks
Secondary outcomes (4)
X-ray
one important clinical imaging data of the premature infants
Measured: up to 4 weeks
complete blood count
complete blood count, one vital laboratory test of the premature infants
Measured: up to 4 weeks
c-reactive protein
c-reactive protein, one vital laboratory test of the premature infants
Measured: up to 4 weeks
procalcitonin
procalcitonin, one vital laboratory test of the premature infants
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start5 Nov 2022 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Enterocolitis of NewbornStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuohui Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zuohui Zhao, Qianfoshan Hospital
- Investigators
- Zuohui Zhao, Dr, Principal investigator, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619055
- Sponsor's protocol ID
- YXLL-KY-2022(018)
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The clinical data to collect for individual participant is not public for the time being.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role and Mechanism of Intestinal Dysbacteriosis Impairing the Intestinal Mucosal Barrier in the Pathogenesis of Necrotizing Enterocolitis in Premature Infants
- ClinicalTrials.gov ID
- NCT05619055
- Acronym / sponsor ID
- YXLL-KY-2022(018)
- Conditions
- Necrotizing Enterocolitis of Newborn
- Keywords
- Necrotizing Enterocolitis, intestinal flora
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zuohui ZhaoUniversity, hospital or other
- Study start
- 5 Nov 2022 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 16 Nov 2022 (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.
Study Description
The goal of this observational study is to detect intestinal flora and the metabolic products in premature infants diagnosed as necrotizing enterocolitis. The main questions it aims to answer are:
- 1. Whether there is intestinal flora in the stool of premature infants.
- 2. Are there dysregulated intestinal flora and their metabolic products in premature infants diagnosed as necrotizing enterocolitis.
- 3. The detailed role and underlying mechanism of the intestinal dysbacteriosis and the metabolic products in premature infants diagnosed as necrotizing enterocolitis.
Participants, premature infants diagnosed as necrotizing enterocolitis (NEC group), will be asked to collect stool (usually 2 times) for intestinal flora analysis.
If there is a comparison group: Researchers will compare premature infants without necrotizing enterocolitis (control group) to see if their intestinal flora and the metabolic products also changed as their NEC counterparts.
Detailed description
When the patients is hospitalized in neonatology, we screen the premature infants according to the selection criteria and exclusion criteria. After sighed the informed consent, they are classified into two groups: premature infants diagnosed as necrotizing enterocolitis (NEC group) and premature infants without necrotizing enterocolitis (control group). Their stool and blood (usually 2 times ) are collected for intestinal flora and FABP (including L-FABP and I-FABP) analysis, respectively.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neonate with necrotizing enterocolitis | – | Other: Routine treatmentpremature infants diagnosed as necrotizing enterocolitis |
| neonate without necrotizing enterocolitis | – | Other: Routine treatmentpremature infants without necrotizing enterocolitis |
Who may qualify
- Ages
- 5 days to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Hospitalized children in Neonatology
Key inclusion criteria (5 listed)
- clinical diagnosis of Necrotizing Enterocolitis,
- gestational age <37 weeks,
- body weight 1,000-2,500 g,
- postnatal Apgar score ≥7,
- initial oral feeding tolerance.
Key exclusion criteria (4 listed)
- serious hereditary or other serious diseases, such as heart, lung and abdominal malformations ,
- early or late onset septicemia,
- early use of antibiotics in the newborn,
- serious adverse reactions caused by probiotics.
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 |
|---|---|---|
| Routine treatmentAntibiotics, intravenous fluids and symptomatic supportive treatment. | Other | neonate with necrotizing enterocolitis, neonate without necrotizing enterocolitis |
Primary outcome
intestinal flora
Time frame: up to 4 weeks
the intestinal flora in the stool using 16S ribosomal RNA(rRNA) gene sequencing
short-chain fatty acids
Time frame: up to 4 weeks
short-chain fatty acids, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing
neurotransmitters
Time frame: up to 4 weeks
neurotransmitters, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing
lipopolysaccharide
Time frame: up to 4 weeks
lipopolysaccharide, a metabolic product of intestinal flora, in the stool using 16S rRNA gene sequencing
L-FABP
Time frame: up to 4 weeks
L-FABP, the injury marker of intestinal mucosa, in the blood
I-FABP
Time frame: up to 4 weeks
I-FABP, the injury marker of intestinal mucosa, in the blood
hospital stay
Time frame: up to 4 weeks
one vital clinical outcome of the premature infants
4 secondary outcomes
X-ray
Time frame: up to 4 weeks
complete blood count
Time frame: up to 4 weeks
c-reactive protein
Time frame: up to 4 weeks
procalcitonin
Time frame: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: Undecided. The clinical data to collect for individual participant is not public for the time being.
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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.
Zuohui Zhao, Dr principal investigator
Shandong First Medical University
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 of Newborn, run by Zuohui Zhao at 1 site in China.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Nov 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zuohui Zhao, Dr (0086-531-89268509, zhaozuohui@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intestinal flora (time frame: up to 4 weeks). The study lists 7 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 16 Nov 2022.