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

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

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

Study Overview

• Status: Recruiting
• Conditions: Neonatal Hyperbilirubinemia
• Intervention / Treatment: Combination product: MDT; Other: control (current management)

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: YIngying B; Phone Number: 086-13777834165; Email: yingyingbao@zju.edu.cn

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • Women's Hospital School of Medicine Zhejiang University
    • Contact: Yuqi Wang; Phone Number: 086-0571-87061501

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study; modified diagnosis and treatment (MDT) for neonatal hemolysis	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: Positive DAT; Significantly elevated ETCOc;; Significant morphological abnormalities Category B: Positive release test;; Elevated ETCOc;; COHb > 1.2%;; Hb < 140 g/L or Hct) < 40%;; 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; Control (current) method for sNH (severe neonatal hemolysis) with the description as follow： 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.; 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); Control (current) method for sNH (severe neonatal hemolysis) with the description as follow： 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.; 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Investigators: Principal Investigator: Yingying Bao, Doctor, Women's Hospital, Zhejiang University School of Medicine; Principal Investigator: Bao, Doctor, Women's Hospital, Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: February 16, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: neonatal hyperbilirubinemia; modified; ETCOc; neonatal hemolysis
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: PRO2024-737; 2025KY929 (Other Identifier: The Medical and Health Research Project of Zhejiang Province)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No