Clinical Trial

Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH

Study acronym: MDTinsNH
Recruiting Early Phase 1
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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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-02-16; most recent amendment 2026-01-15.
Status change: Not Yet Recruiting → Recruiting 2026-01-15
Trial Details
NCT Number NCT06832800
Lead Sponsor Women's Hospital School Of Medicine Zhejiang University
Conditions Neonatal Hyperbilirubinemia
Enrollment 250 participants
Start Date 2025-07-21
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-20