Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH
Recruiting now · Early Phase 1
Conditions studied: Neonatal Hyperbilirubinemia
In brief
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
Key facts
- Study ID
- NCT06832800
- Run by
- Women's Hospital School Of Medicine Zhejiang University
- People needed
- 250
- Starts
- 2025-07-21
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-01-20
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Infants with definite congenital genetic metabolic diseases, chromosomal or genetic disorders, or severe malformations.
Where it is running
- Women's Hospital School of Medicine Zhejiang University — Hangzhou, China (enrolling)
Full record on ClinicalTrials.gov
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