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Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH

Study acronym: MDTinsNH
StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 20, 2025 to Jul 21, 2025
    • Study sites: 0 to 1
    v3
  2. Start date: Mar 1, 2025 to Mar 20, 2025v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06832800
Lead Sponsor Women's Hospital School Of Medicine Zhejiang University
Conditions
(from sponsor)		 Neonatal Hyperbilirubinemia
Related terms Hyperbilirubinemia, Neonatal
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov