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

January 31, 2025 updated by: Women's Hospital School Of Medicine Zhejiang University

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Hangzhou, China
        • Recruiting
        • Women's Hospital School Of Medicine Zhejiang University
        • Contact:
          • Yingying Bao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

positive in diagnosis of ABO-HDN

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ABO HDN
positive in diagnosis of ABO-HDN
non ABO HDN
negative in diagnosis of ABO-HDN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
concentration of ETCOc (end tidal carbon monoxide)
Time Frame: through study completion, planned to be 1.5 year
ETCOc in ppm
through study completion, planned to be 1.5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
concentration of bilirubin
Time Frame: through study completion, planned to be 1.5 year
bilirubin in mg/dl
through study completion, planned to be 1.5 year
result of DAT
Time Frame: through study completion, planned to be 1.5 year
DAT result of positive or negtive
through study completion, planned to be 1.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Investigators

  • Principal Investigator: Yingying Bao, M.M., Women's Hospital School Of Medicine Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2023

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 10, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETCOc in ABO-HDN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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