Research of Diagnostic Value for BMJ Infants

NCT04527536 | Unknown

• 1 other identifier: ShanghaiFMIH-2020-084
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Jaundice, Neonatal

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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

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

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

Interventions

Neonatal hyperbilirubinemia DIAGNOSTIC_TEST

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

early-set BMJ group; healthy control; late-onset BMJ group

Eligibility Criteria

• Age: 4 Days - 42 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jing Li, Doctorate

  Shanghai First Maternity and Infant Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Li, Doctorate

CONTACT

01861358683669; zzhlq3@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 26, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: August 26, 2020

Record last verified: 2020-08