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Breast milk jaundice (BMJ) is the main cause of neonatal hyperbilirubinemia. Excessive serum unconjugated bilirubin level will not only cause the interruption or early termination of breastfeeding, but also cause kernicterus. Which can cause long-term dysfunction in infants. But for a long time, BMJ diagnosis has relied on clinical exclusive methods, lack of objective and reliable laboratory indicators. Which leads to misdiag. This project is a single-center, prospective nested case-control study. It is planned to establish a neonatal BMJ cohort. According to the admission criteria, 100 cases of early-onset BMJ and late-onset BMJ will be completed, and 100 healthy controls collected during the same period. , Compare the detection results of fecal miRNA and intestinal flora of the two groups of BMJ children and healthy controls, draw the ROC curve of the joint diagnosis, conduct research on the combined diagnostic value of fecal miRNA and intestinal flora analysis, and try to find the feasibility and practical value of diagnostic markers for feces in infants with BMJ.
This project is a single-center, prospective nested case-control study to investigate feasibility and practical value of diagnostic markers in infants with BMJ.
According to the admission criteria, 100 cases of early-onset BMJ, 100 late-onset BMJ and 100 healthy controls will be selected. Their feces, peripheral venous blood and mothers' breast milk were collected for further testing. Compare the detection results of fecal miRNA and intestinal flora of the two groups of BMJ children and healthy controls, draw the ROC curve of the joint diagnosis, conduct research on the combined diagnostic value of fecal miRNA and intestinal flora analysis.
This study is to find the objective and reliable laboratory indicators to diagnose BMJ.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early-set BMJ group | Infants were admitted to our hospital at 4-7 days of age and were followed up to 28 days. Other pathological jaundice factors were excluded.Those who met the criteria were the early-onset BMJ group. |
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| late-onset BMJ group | Infants were admitted to our hospital after 7 days of age and were followed up to 28-42 days or until the jaundice disappeared. Other pathological jaundice factors were excluded..Those who met the criteria were late-onset BMJ |
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| healthy control | During the same period, the healthy newborns who were born in the obstetrics department of our hospital. These newborns were mainly breastfed or breastfed, and grew well. They were enrolled at 7-14 days of age and were followed up to 28-42 days without pathological jaundice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neonatal hyperbilirubinemia | Diagnostic Test | Neonatal hyperbilirubinemia:The total serum bilirubin exceeds the 95th percentile of the Bhutani neonatal hourly bilirubin nomogram. |
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| Measure | Description | Time Frame |
|---|---|---|
| Analysis of breast milk exosomes miRNA | Analysis of breast milk exosomes miRNA | 2021.10.01-2022.09.30 |
| Analysis of newborn feces miRNA and intestinal flora analysis | Analysis of newborn feces miRNA and intestinal flora analysis | 2021.10.01-2022.09.30 |
| UGT1A1 test in newborn blood | UGT1A1 test in newborn blood | 2021.10.01-2022.09.30 |
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Inclusion Criteria:
All the following conditions must be met
Exclusion Criteria:
As long as any one of the following conditions should be excluded
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Newborn babies born from research start who diagnosed neonatal hyperbilirubinemia and healthy newborns
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Li, Doctorate | Contact | 01861358683669 | zzhlq3@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Li, Doctorate | Shanghai First Maternity and Infant Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D007567 | Jaundice, Neonatal |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |