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

Recruiting

• Conditions: ABO Hemolytic Disease of Newborn

• Registration Number: NCT05842109
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

Brief 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.

Study Timeline

• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-05-02
• Study First Posted: 2023-05-03
• Study Start: 2023-10-31
• Status Verified: 2024-04
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
concentration of ETCOc (end tidal carbon monoxide)	through study completion, planned to be 1.5 year	ETCOc in ppm

Secondary Outcome Measures

Name	Time	Method
concentration of bilirubin	through study completion, planned to be 1.5 year	bilirubin in mg/dl
result of DAT	through study completion, planned to be 1.5 year	DAT result of positive or negtive

Trial Locations

Locations (1)

Women's hospital School of medicine Zhejiang University; 🇨🇳 Hangzhou, China