Clinical trial NCT05619055: The Intestinal Dysbacteriosis in the Pathogenesis of Necrotizing Enterocolitis
Official title: The Role and Mechanism of Intestinal Dysbacteriosis Impairing the Intestinal Mucosal Barrier in the Pathogenesis of Necrotizing Enterocolitis in Premature Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Necrotizing Enterocolitis of Newborn
Keywords: Necrotizing Enterocolitis
intestinal flora
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized children in Neonatology

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of Necrotizing Enterocolitis,
* gestational age \<37 weeks,
* body weight 1,000-2,500 g,
* postnatal Apgar score ≥7,
* initial oral feeding tolerance.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: intestinal flora
timeFrame: up to 4 weeks
measure: short-chain fatty acids
timeFrame: up to 4 weeks
measure: neurotransmitters
timeFrame: up to 4 weeks
measure: lipopolysaccharide
timeFrame: up to 4 weeks
measure: L-FABP
timeFrame: up to 4 weeks
measure: I-FABP
timeFrame: up to 4 weeks
measure: hospital stay
timeFrame: up to 4 weeks
Secondary outcomes:
measure: X-ray
timeFrame: up to 4 weeks
measure: complete blood count
timeFrame: up to 4 weeks
measure: c-reactive protein
timeFrame: up to 4 weeks
measure: procalcitonin
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: Zuohui Zhao, Dr
role: PRINCIPAL_INVESTIGATOR
References: