Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH

NCT06832800 | Recruiting Early Phase 1

• 2 other identifiers: PRO2024-7372025KY929
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

ETCOc; neonatal hemolysis; neonatal hyperbilirubinemia; modified

Outcome Measures

Primary Outcomes (1)

• neural damage confirmed by professional assessments such as Bayley Scales

  Neurological impairment, including any of the following: diagnosis of cerebral palsy, diagnostic hearing tests indicating hearing impairment, or a score lower than 85 on the Bayley Scales Neurobehavioral Assessment. Bayley Scales means Bayley Scales of Infant and Toddler Development and it can assess the neural development of infants including Cognitive, Language (Receptive/Expressive), Motor (Fine/Gross), Social-Emotional, and Adaptive Behavior. Standard scores for each domain range from 40 to 160 (mean = 100; SD = 15). Higher scores indicate better developmental outcomes, while lower scores suggest potential delays. For example, a cognitive score of 115 reflects performance above the average range, whereas a score of 85 falls below the average range.

  at the age of 12 months

Study Arms (2)

study

EXPERIMENTAL

modified diagnosis and treatment (MDT) for neonatal hemolysis

Combination Product: MDT

control

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;

Other: control (current management)

Interventions

MDT 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.

study

control (current management) 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;

control

Eligibility Criteria

• Age: 4 Hours - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Infants with definite congenital genetic metabolic diseases, chromosomal or genetic disorders, or severe malformations.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yingying Bao, Doctor

  Women's Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

• Bao, Doctor

  Women's Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YIngying B

CONTACT

086-13777834165; yingyingbao@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 18, 2025
• Study Start: July 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 20, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)