An observational study to explore the use of end-tidal carbon monoxide corrected for ambient CO (ETCOc) in diagnosing and treating hemolytic disease of the fetus and newborn (HDFN) is currently recruiting new participants.
The study, which will take place at the Women’s Hospital School Of Medicine Zhejiang University, China, aims to recruit 112 neonates with elevated bilirubin levels and ABO incompatibility.
Other inclusion criteria include:
- Gestational age between 35 weeks and 41 weeks, 6 days
- Birth weight of at least 2500 grams
- Respiratory rate less than 60 breaths per minute
Patients will be classified as hemolytic or non-hemolytic on the basis of serological testing. The investigators will then follow up the participants for a period of approximately 1.5 years to gather outcome data.
The primary outcome measure of the study is ETCOc concentration. This can be gathered through a simple, non-invasive test that measures the amount of carbon monoxide exhaled, which is a marker of red blood cell destruction. The secondary outcome measures include bilirubin concentration and direct antiglobulin test results.
Read more about HDFN testing and diagnosis
The study plans to compare the primary and secondary outcomes between those with and without HDFN, as well as between those with hemolysis who did and did not receive intravenous immunoglobulin. From these results, they hope to better understand the value of ETCOc and other indicators not only in cases of HDFN versus controls, but also in different treatment groups among those with HDFN.
Patients who require respiratory support, have damage to the nasal cavity, have been admitted to the neonatal intensive care unit, or have any severe congenital or genetic abnormalities are ineligible for participation.
The study is estimated to be completed by the end of 2026.
Sign up here to get the latest news, perspectives, and information about HDFN sent directly to your inbox. Registration is free and only takes a minute.
