Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age4-28
SponsorWomen's Hospital School Of Medicine Zhejiang University

About this trial

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

Eligibility criteria

Qualifiers

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).

Disqualifiers

Infants with definite congenital genetic metabolic diseases, chromosomal or genetic disorders, or severe malformations.

Trial design

Treatments tested in this trial

  • MDT
  • control (current management)

Treatment groups

250 Participants
are divided into 2 treatment groups