NCT06832800

Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: All
• Age: 4 Hours – 28 Days
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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 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.
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 exchange transfusion threshold;

Timeline

• Start date: 2025-07-21
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-02-18
• Last updated: 2026-01-20

Locations

1 site across 1 country: China