Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MDT, control (current management).
- Who it may be relevant to
- Registry conditions: Neonatal Hyperbilirubinemia. Basic parameters: 4 Hours — 28 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Modified Diagnosis and Treatment of Neonatal Hemolysis Incorporated With ETCOc Measurement in Severe Neonatal Hyperbilirubinemia Management
Overview
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
Interventions
- Combination product MDT
（actually not combination product, but have to select that option in order to delete warning in "study desine"）MDT method for sNH with the description as follow： 1. diagnosis of neonatal hemolysis： The neonatal subjects with symptom of hyperbilirubinemia are diagnosed as hemolysis if they met one criterion from Category A or two criteria from Category B: Category A: 1. Positive DAT 2. Significantly elevated ETCOc; 3. Significant morphological abnormalities Category B: 1. Positive release te - Other control (current management)
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 e
Primary outcome measures
- neural damage confirmed by professional assessments such as Bayley Scales [Time frame: at the age of 12 months]
Eligibility criteria
Inclusion Criteria: Inclusion Criteria:
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).
Exclusion criteria
- Infants with definite congenital genetic metabolic diseases, chromosomal or genetic disorders, or severe malformations.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Women's Hospital School of Medicine Zhejiang University — Hangzhou
Identifiers
NCT: NCT06832800 · PRO2024-737 · 2025KY929