NCT04527536

Research of Diagnostic Value for BMJ Infants

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Shanghai First Maternity and Infant Hospital · Academic / Other
• Sex: All
• Age: 4 Days – 42 Days
• Healthy volunteers: —

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.

Conditions

• Jaundice, Neonatal

Interventions

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

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2020-08-26
• Last updated: 2020-08-26