Research of Diagnostic Value for BMJ Infants

Research of Diagnostic Value of Fecal miRNA and Intestinal Flora in Infants With BMJ

Sponsors

Lead Sponsor: Shanghai First Maternity and Infant Hospital

Source Shanghai First Maternity and Infant Hospital
Brief Summary

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.

Detailed Description

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.

Overall Status Not yet recruiting
Start Date 2020-10-01
Completion Date 2022-09-30
Primary Completion Date 2022-09-30
Study Type Observational
Primary Outcome
Measure Time Frame
Analysis of breast milk exosomes miRNA 2021.10.01-2022.09.30
Analysis of newborn feces miRNA and intestinal flora analysis 2021.10.01-2022.09.30
UGT1A1 test in newborn blood 2021.10.01-2022.09.30
Enrollment 300
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Neonatal hyperbilirubinemia

Description: Neonatal hyperbilirubinemia:The total serum bilirubin exceeds the 95th percentile of the Bhutani neonatal hourly bilirubin nomogram.

Eligibility

Sampling Method:

Probability Sample

Criteria:

Inclusion Criteria: - All the following conditions must be met 1. Term newborns admitted to hospital with "neonatal hyperbilirubinemia" 2. Exclusive breastfeeding or mainly breastfeeding 3. Exclude perinatal infection, G-6P-D deficiency, homoimmune hemolysis, polycythemia, scalp hematoma, intracranial hemorrhage, cholestasis, hypoglycemia, hypothyroidism, hypothermia, neonatal asphyxia, fetus Pathological jaundice factors such as delayed stool excretion. Exclusion Criteria: - As long as any one of the following conditions should be excluded 1. During the follow-up period, breastfeeding was terminated or the daily milk powder intake exceeded 200 ml. 2. Other pathological jaundice was diagnosed during the follow-up period. 3. Take probiotics during the sampling period. 4. The guardian asked to withdraw from the study halfway.

Gender:

All

Minimum Age:

N/A

Maximum Age:

42 Days

Overall Official
Last Name Role Affiliation
Jing Li, Doctorate Principal Investigator Shanghai First Maternity and Infant Hospital
Overall Contact

Last Name: Jing Li, Doctorate

Phone: 01861358683669

Email: [email protected]

Verification Date

2020-08-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: early-set BMJ group

Description: 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.

Label: late-onset BMJ group

Description: 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

Label: healthy control

Description: 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.

Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News