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Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH

RecruitingEARLY Phase 1Ages 4 Hours - 28 DaysAllWomen's Hospital School Of Medicine Zhejiang Univ…
NCT06832800 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ma

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📋 Eligibility rules (as published)
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.
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What it tests

  • MDT
  • control (current management)
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Where

1 site
Women's Hospital School of Medicine Zhejiang University
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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