Modified Diagnosis and Treatment of Neonatal Hemolysis Incorporated With ETCOc Measurement in Severe Neonatal Hyperbilirubinemia Management

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Other
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The goal of this clinical trial is to learn if modified diagnosis and treatment (MDT) of neonatal hemolysis (a common cause to newborn jaundice) incorporated with ETCOc measurement (a non-invasive measurement of exhaled gas) works to prevent brain damage in newborns with severe hyperbilirubinemia (sNH). It will also learn about the. occurrence of cranial MRI in the study participants. The main questions it aims to answer are: * Does MDT lower the possibilities participants have brain damage before the age of one? * How many times of abnormalities in cranial MRI is detected before the age of one? Researchers will compare MDT to a control (a current management) to see if MDT works to prevent brain damage in newborns with sHN. Participants will: * Take MDT or a control method in the management of sNH * Assess if there's brain damage before discharge and at the year of one * Record how many times of abnormalities in cranial MRI is detected before the age of one

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 28 days
Healthy Volunteers: f
View:

⁃ Infants with gestational age of 35(+0) to 41(+6) weeks and birth weight ≥ 2500 grams

• Infants with severe neonatal hyperbilirubinemia, including those whose serum total

• bilirubin (TSB) levels reach above 20 mg/dL or whose TSB levels at any time reach within 2 mg/dL of the exchange transfusion threshold (i.e., TSB \> (threshold - 2) mg/dL).

Locations
Other Locations
China
Women's Hospital School of Medicine Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
YIngying B
yingyingbao@zju.edu.cn
086-13777834165
Time Frame
Start Date: 2025-07-21
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 250
Treatments
Experimental: study
modified diagnosis and treatment (MDT) for neonatal hemolysis
Other: control
Control (current) method for sNH (severe neonatal hemolysis) with the description as follow:~1. Diagnosis of neonatal hemolysis: The neonatal subjects with symptom of hyperbilirubinemia are diagnosed as hemolysis if they have positive Direct Antiglobulin Test (DAT) or positive release test result.~2. Exchange transfusion (ET) therapy for sNH: The neonatal subjects with symptom of hyperbilirubinemia are treated with ET therapy if their Total serum bilirubin (TSB) reaches or exceeds the current exchange transfusion threshold;
Sponsors
Leads: Women's Hospital School Of Medicine Zhejiang University

This content was sourced from clinicaltrials.gov

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