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Search / Trial NCT05842109

Clinical Value of ETCOc in the Diagnosis and Treatment of ABO-HDN

Launched by WOMEN'S HOSPITAL SCHOOL OF MEDICINE ZHEJIANG UNIVERSITY · May 2, 2023

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

End Tidal Carbon Monoxide Hyperbilirubinemia Abo Hemolytic Disease Of Newborn

ClinConnect Summary

This clinical trial is studying a condition called ABO Hemolytic Disease of the Newborn, which can occur when a mother’s blood type is incompatible with her baby’s. The researchers are looking at a special measurement called ETCOc to see how helpful it is in diagnosing and treating this condition. They will compare different clinical indicators, like bilirubin levels (a substance that can build up and cause jaundice) and a blood test called the direct antiglobulin test, between babies who are affected by the disease and those who are not. They will also examine how well ETCOc works in babies who receive a treatment called IVIG compared to those who do not.

To participate in this study, babies need to meet certain criteria. They should be between 35 and 42 weeks old at birth, weigh at least 2500 grams, and have been admitted to the hospital for treatment of jaundice. They also need to have a blood type mismatch with their mother. However, babies with breathing difficulties, serious skin issues, or major health problems are not eligible. If your baby qualifies and you decide to join, you can expect to provide consent and have their health monitored closely during the study. This research aims to improve how we diagnose and treat this condition, potentially leading to better outcomes for affected newborns.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • gestational age between 35+0 and 41+6 weeks
  • birth weight ≥ 2500 grams
  • respiratory rate \< 60 breaths per minute
  • the neonates admitted to the neonatology department for phototherapy because of hyperbilirubinemia that conforms to the guideline of the experts consensus on the management of neonatal hyperbilirubinemia(2014,in China.)
  • ABO group incompatibility between the mother and newborn
  • the informed consent are obtained.
  • Exclusion Criteria:
  • persistent dyspnea or need for respiratory support
  • skin damage or structural deformity around the nasal cavity
  • receive intensive care treatment in the neonatal intensive care unit(NICU)
  • Severe congenital malformation, chromosomal or genetic abnormality

About Women's Hospital School Of Medicine Zhejiang University

The Women’s Hospital School of Medicine at Zhejiang University is a leading academic institution dedicated to advancing women's health through innovative research and clinical excellence. With a strong focus on obstetrics, gynecology, and reproductive health, the institution conducts cutting-edge clinical trials aimed at improving patient outcomes and enhancing the understanding of women's health issues. Committed to fostering collaboration between researchers, healthcare professionals, and patients, the Women's Hospital School of Medicine plays a pivotal role in translating scientific discoveries into effective healthcare solutions.

Locations

Hangzhou, , China

Patients applied

0 patients applied

Trial Officials

Yingying Bao, M.M.

Principal Investigator

Women's Hospital School Of Medicine Zhejiang University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported