Actively Recruiting

Early Phase 1
Age: 4Hours - 28Days
All Genders
NCT06832800

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

Age: 4Hours - 28Days
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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