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Research of Diagnostic Value for BMJ Infants

NCT04527536 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2020-08-26

No results posted yet for this study

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.

Conditions

  • Jaundice, Neonatal

Interventions

DIAGNOSTIC_TEST

Neonatal hyperbilirubinemia

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

Sponsors & Collaborators

  • Shanghai First Maternity and Infant Hospital

    lead OTHER

Principal Investigators

  • Jing Li, Doctorate · Shanghai First Maternity and Infant Hospital

Eligibility

Min Age
4 Days
Max Age
42 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-09-30
Completion
2022-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04527536 on ClinicalTrials.gov