Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH

NCT ID: NCT06832800

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-21
• Study Completion Date: 2027-12-31

Brief 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

Conditions

Neonatal Hyperbilirubinemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

study

modified diagnosis and treatment (MDT) for neonatal hemolysis

Group Type: EXPERIMENTAL

MDT

Intervention Type: COMBINATION_PRODUCT

（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 test;

2. Elevated ETCOc;

3. COHb > 1.2%;

4. Hb < 140 g/L or Hct) < 40%;

5. Ret > 6%. 2.Exchange transfusion (ET) therapy for sNH： any of the following criteria are met:

(1) TSB ≥ the current ET threshold; (2) TSB > (ET - 2) mg/dL or the increase of TSB > 0.5 mg/dL/h, accompanied by abnormal aEEG findings; (3) TSB > (ET - 2) mg/dL or > 0.5 mg/dL/h, accompanied by a BIND score of 4-6; (4) Presence of clinical manifestations of acute ABE; (5) BIND score of 7-9.

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;

Group Type: OTHER

control (current management)

Intervention Type: OTHER

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;

Interventions

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 test;

2. Elevated ETCOc;

3. COHb > 1.2%;

4. Hb < 140 g/L or Hct) < 40%;

5. Ret > 6%. 2.Exchange transfusion (ET) therapy for sNH： any of the following criteria are met:

(1) TSB ≥ the current ET threshold; (2) TSB > (ET - 2) mg/dL or the increase of TSB > 0.5 mg/dL/h, accompanied by abnormal aEEG findings; (3) TSB > (ET - 2) mg/dL or > 0.5 mg/dL/h, accompanied by a BIND score of 4-6; (4) Presence of clinical manifestations of acute ABE; (5) BIND score of 7-9.

Intervention Type: COMBINATION_PRODUCT

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 exchange transfusion threshold;

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 4 Hours
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yingying Bao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Women's Hospital, Zhejiang University School of Medicine

Bao, Doctor

Role: PRINCIPAL_INVESTIGATOR

Women's Hospital, Zhejiang University School of Medicine

Locations

Women's Hospital School of Medicine Zhejiang University

Hangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

YIngying B

Role: CONTACT

yingyingbao@zju.edu.cn

086-13777834165

Facility Contacts

Yuqi Wang

Role: primary

086-0571-87061501

Other Identifiers

2025KY929

Identifier Type: OTHER

Identifier Source: secondary_id

PRO2024-737

Identifier Type: -

Identifier Source: org_study_id