Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH

Launched by WOMEN'S HOSPITAL SCHOOL OF MEDICINE ZHEJIANG UNIVERSITY · Feb 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to diagnose and treat a condition called neonatal hyperbilirubinemia, which is a common cause of jaundice in newborns. The goal is to see if a modified approach, combined with a simple test that measures gases in a baby’s breath, can help prevent brain damage in babies with severe jaundice. Researchers want to find out if this new method can reduce the chances of brain damage and how many babies show abnormalities in brain scans before they turn one year old.

To participate in this trial, babies must be between 0 and 28 days old, born between 35 and 41 weeks of pregnancy, and weigh at least 2,500 grams. They should have severe jaundice, meaning their bilirubin levels are very high. However, babies with certain genetic disorders or severe birth defects cannot join the study. Participants will receive either the new treatment or the standard care and will be monitored for brain health and any issues found in brain scans until they reach one year of age. This trial is not yet recruiting participants, but it aims to gather important information that could improve care for newborns with jaundice in the future.

Gender

ALL

Eligibility criteria

• 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.