Necrotizing Enterocolitis of Newborn
Conditions
Keywords
Necrotizing Enterocolitis, intestinal flora
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.
Interventions
OTHERRoutine treatment
Antibiotics, intravenous fluids and symptomatic supportive treatment.
Sponsors
Zuohui Zhao
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
5 Days to 2 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hospital stay | up to 4 weeks | one vital clinical outcome of the premature infants |
| neurotransmitters | up to 4 weeks | neurotransmitters, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing |
| lipopolysaccharide | up to 4 weeks | lipopolysaccharide, a metabolic product of intestinal flora, in the stool using 16S rRNA gene sequencing |
| L-FABP | up to 4 weeks | L-FABP, the injury marker of intestinal mucosa, in the blood |
| I-FABP | up to 4 weeks | I-FABP, the injury marker of intestinal mucosa, in the blood |
| intestinal flora | up to 4 weeks | the intestinal flora in the stool using 16S ribosomal RNA(rRNA) gene sequencing |
| short-chain fatty acids | up to 4 weeks | short-chain fatty acids, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complete blood count | up to 4 weeks | complete blood count, one vital laboratory test of the premature infants |
| c-reactive protein | up to 4 weeks | c-reactive protein, one vital laboratory test of the premature infants |
| procalcitonin | up to 4 weeks | procalcitonin, one vital laboratory test of the premature infants |
| X-ray | up to 4 weeks | one important clinical imaging data of the premature infants |
Countries
China
Contacts
Primary ContactZuohui Zhao, Dr
Backup ContactJiahui Li, Dr
Outcome results
None listed