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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05842109
Enrollment
112
Registered
2023-05-03
Start date
2023-10-31
Completion date
2026-12-31
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ABO Hemolytic Disease of Newborn

Keywords

End tidal carbon monoxide, hyperbilirubinemia, ABO Hemolytic Disease of Newborn

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.

Interventions

None listed

Sponsors

Women's Hospital School Of Medicine Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 7 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
concentration of ETCOc (end tidal carbon monoxide)through study completion, planned to be 1.5 yearETCOc in ppm

Secondary

MeasureTime frameDescription
concentration of bilirubinthrough study completion, planned to be 1.5 yearbilirubin in mg/dl
result of DATthrough study completion, planned to be 1.5 yearDAT result of positive or negtive

Countries

China

Contacts

Primary ContactYingying Bao, M.M.
yingyingbao@zju.edu.cn13777834165
Backup ContactChuncai Xu, M.M.
chuncaixu@zju.edu.cn15257168032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026