Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH (MDTinsNH)

Women's Hospital School Of Medicine Zhejiang University

Status and phase: Enrolling; Early Phase 1

Conditions: Neonatal Hyperbilirubinemia

Treatments: Other: control (current management); Combination Product: MDT

Study type: Interventional

Funder types: Other

Identifiers

NCT06832800

PRO2024-737

2025KY929 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: All

Ages: 4 hours to 28 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

study

Experimental group

Description:

modified diagnosis and treatment (MDT) for neonatal hemolysis

Treatment:

Combination Product: MDT

control

Other group

Description:

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;

Treatment:

Other: control (current management)