Status:

UNKNOWN

Research of Diagnostic Value for BMJ Infants

Lead Sponsor:

Shanghai First Maternity and Infant Hospital

Conditions:

Jaundice, Neonatal

Eligibility:

All Genders

4-42 years

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, bu...

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, 1...

Eligibility Criteria

Inclusion

  • All the following conditions must be met
  • Term newborns admitted to hospital with "neonatal hyperbilirubinemia"
  • Exclusive breastfeeding or mainly breastfeeding
  • 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

  • As long as any one of the following conditions should be excluded
  • During the follow-up period, breastfeeding was terminated or the daily milk powder intake exceeded 200 ml.
  • Other pathological jaundice was diagnosed during the follow-up period.
  • Take probiotics during the sampling period.
  • The guardian asked to withdraw from the study halfway.

Key Trial Info

Start Date :

October 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 30 2022

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT04527536

Start Date

October 1 2020

End Date

September 30 2022

Last Update

August 26 2020

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