The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis
NCT ID: NCT05619055
Last Updated: 2022-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2022-11-05
2025-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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neonate with necrotizing enterocolitis
premature infants diagnosed as necrotizing enterocolitis
Routine treatment
Antibiotics, intravenous fluids and symptomatic supportive treatment.
neonate without necrotizing enterocolitis
premature infants without necrotizing enterocolitis
Routine treatment
Antibiotics, intravenous fluids and symptomatic supportive treatment.
Interventions
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Routine treatment
Antibiotics, intravenous fluids and symptomatic supportive treatment.
Eligibility Criteria
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Inclusion Criteria
* gestational age \<37 weeks,
* body weight 1,000-2,500 g,
* postnatal Apgar score ≥7,
* initial oral feeding tolerance.
Exclusion Criteria
* early or late onset septicemia,
* early use of antibiotics in the newborn,
* serious adverse reactions caused by probiotics.
5 Days
2 Months
ALL
Yes
Sponsors
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Zuohui Zhao
OTHER
Responsible Party
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Zuohui Zhao
Associate professor
Principal Investigators
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Zuohui Zhao, Dr
Role: PRINCIPAL_INVESTIGATOR
Shandong First Medical University
Locations
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The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YXLL-KY-2022(018)
Identifier Type: -
Identifier Source: org_study_id
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