NCT05842109

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

Clinical Value of ETCOc in the Diagnosis and Treatment of ABO Hemolytic Disease of the Newborn

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 112 (estimated)
• Sponsor: Women's Hospital School Of Medicine Zhejiang University · Academic / Other
• Sex: All
• Age: 7 Days
• Healthy volunteers: Not accepted

Summary

A prospective observational cohort study was designed. 1. Comparing of the clinical indicators between the hemolytic group and the non-hemolytic group,such as End-tidal carbon monoxide corrected for ambient CO(ETCOc),direct antiglobulin test(DAT), the highest total serum bilirubin level and hemoglobin. To explore the role of ETCOc in the diagnosis of neonatal ABO hemolytic disease. 2. Comparing of the clinical indicators between the neonates with IVIG treatment and the neonates without IVIG treatment in ABO hemolytic disease, such as ETCOc,total serum bilirubin level before IVIG treatment and ETCOc,total serum bilirubin level after IVIG treatment.To explore the clinical value of ETCOc in the treatment of ABO hemolytic disease.

Detailed description

A prospective observational cohort study was designed. The participants included in the study are the neonates with hyperbilirubinemia in ABO incompatibility.Because the serological results are not known at the time of enrollment, all the neonates should be suspected hemolysis. According to the serological results,the neonates are divided into two groups, hemolytic group and non-hemolytic group. All the relevant clinical indicators need to be recorded and each neonates needs follow-up.

Conditions

• ABO Hemolytic Disease of Newborn

Timeline

• Start date: 2023-10-31
• Primary completion: 2025-10-31
• Completion: 2026-12-31
• First posted: 2023-05-03
• Last updated: 2025-02-05

Locations

1 site across 1 country: China