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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neonate with necrotizing enterocolitis | premature infants diagnosed as necrotizing enterocolitis |
| |
| neonate without necrotizing enterocolitis | premature infants without necrotizing enterocolitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine treatment | Other | Antibiotics, intravenous fluids and symptomatic supportive treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| intestinal flora | the intestinal flora in the stool using 16S ribosomal RNA(rRNA) gene sequencing | 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 | up to 4 weeks |
| neurotransmitters | neurotransmitters, the metabolic products of intestinal flora, in the stool using 16S rRNA gene sequencing | up to 4 weeks |
| lipopolysaccharide | lipopolysaccharide, a metabolic product of intestinal flora, in the stool using 16S rRNA gene sequencing | up to 4 weeks |
| L-FABP | L-FABP, the injury marker of intestinal mucosa, in the blood | up to 4 weeks |
| I-FABP | I-FABP, the injury marker of intestinal mucosa, in the blood | up to 4 weeks |
| hospital stay | one vital clinical outcome of the premature infants | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| X-ray | one important clinical imaging data of the premature infants | up to 4 weeks |
| complete blood count | complete blood count, one vital laboratory test of the premature infants |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized children in Neonatology
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zuohui Zhao, Dr | Contact | 0086-531-89268509 | zhaozuohui@126.com | |
| Jiahui Li, Dr | Contact | 0086-531-89268508 | 2149@sdhospital.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zuohui Zhao, Dr | Shandong First Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University | Recruiting | Jinan | Shandong | China |
The clinical data to collect for individual participant is not public for the time being.
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| up to 4 weeks |
| c-reactive protein | c-reactive protein, one vital laboratory test of the premature infants | up to 4 weeks |
| procalcitonin | procalcitonin, one vital laboratory test of the premature infants | up to 4 weeks |
| D007410 |
| Intestinal Diseases |