Actively Recruiting
Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH
Led by Women's Hospital School Of Medicine Zhejiang University · Updated on 2026-01-20
250
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born between 35 weeks 0 days and 41 weeks 6 days of gestation
- Birth weight of at least 2500 grams
- Severe neonatal hyperbilirubinemia, with total serum bilirubin (TSB) above 20 mg/dL or within 2 mg/dL of the exchange transfusion threshold
You will not qualify if you...
- Infants with definite congenital genetic metabolic diseases
- Infants with chromosomal or genetic disorders
- Infants with severe malformations
AI-Screening
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Trial Site Locations
Total: 1 location
1
Women's Hospital School of Medicine Zhejiang University
Hangzhou, China
Actively Recruiting
Research Team
Y
YIngying B
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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