Research of Diagnostic Value for BMJ Infants

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

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.

Study Overview

• Status: Unknown
• Conditions: Jaundice, Neonatal
• Intervention / Treatment: Diagnostic test: Neonatal hyperbilirubinemia

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Jing Li, Doctorate; Phone Number: 01861358683669; Email: zzhlq3@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 days to 1 month (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Newborn babies born from research start who diagnosed neonatal hyperbilirubinemia and healthy newborns

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Neonatal hyperbilirubinemia; Neonatal hyperbilirubinemia：The total serum bilirubin exceeds the 95th percentile of the Bhutani neonatal hourly bilirubin nomogram.
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	Diagnostic test: Neonatal hyperbilirubinemia; Neonatal hyperbilirubinemia：The total serum bilirubin exceeds the 95th percentile of the Bhutani neonatal hourly bilirubin nomogram.
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.	Diagnostic test: Neonatal hyperbilirubinemia; Neonatal hyperbilirubinemia：The total serum bilirubin exceeds the 95th percentile of the Bhutani neonatal hourly bilirubin nomogram.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shanghai First Maternity and Infant Hospital
• Investigators: Principal Investigator: Jing Li, Doctorate, Shanghai first maternity and infant hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2020
• Primary Completion (ANTICIPATED): September 30, 2022
• Study Completion (ANTICIPATED): September 30, 2022

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (ACTUAL): August 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal
• Other Study ID Numbers: ShanghaiFMIH-2020-084

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No