Research of Diagnostic Value for BMJ Infants

NCT ID: NCT04527536

Last Updated: 2020-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-09-30

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.

Conditions

Jaundice, Neonatal

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Neonatal hyperbilirubinemia

Intervention Type: DIAGNOSTIC_TEST

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

Neonatal hyperbilirubinemia

Intervention Type: DIAGNOSTIC_TEST

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.

Neonatal hyperbilirubinemia

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Neonatal hyperbilirubinemia

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 4 Days
• Maximum Eligible Age: 42 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Li, Doctorate

Role: PRINCIPAL_INVESTIGATOR

Shanghai First Maternity and Infant Hospital

Central Contacts

Jing Li, Doctorate

Role: CONTACT

zzhlq3@qq.com

01861358683669

Other Identifiers

ShanghaiFMIH-2020-084

Identifier Type: -

Identifier Source: org_study_id