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

Sponsor
Women's Hospital School Of Medicine Zhejiang University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05842109
Collaborator
(none)
112
Enrollment
18
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    112 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Clinical Value of ETCOc in the Diagnosis and Treatment of ABO Hemolytic Disease of the Newborn
    Anticipated Study Start Date :
    May 1, 2023
    Anticipated Primary Completion Date :
    Apr 30, 2024
    Anticipated Study Completion Date :
    Oct 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    ABO HDN

    positive in diagnosis of ABO-HDN
    non ABO HDN

    negative in diagnosis of ABO-HDN

    Outcome Measures

    Primary Outcome Measures

    1. concentration of ETCOc (end tidal carbon monoxide) [through study completion, planned to be 1.5 year]

      ETCOc in ppm

    Secondary Outcome Measures

    1. concentration of bilirubin [through study completion, planned to be 1.5 year]

      bilirubin in mg/dl

    2. result of DAT [through study completion, planned to be 1.5 year]

      DAT result of positive or negtive

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 7 Days
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Women's Hospital School Of Medicine Zhejiang University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Women's Hospital School Of Medicine Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT05842109
    Other Study ID Numbers:
    • ETCOc in ABO-HDN
    First Posted:
    May 3, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Women's Hospital School Of Medicine Zhejiang University
    End tidal carbon monoxide
    hyperbilirubinemia
    ABO Hemolytic Disease of Newborn
    Additional relevant MeSH terms:
    Erythroblastosis, Fetal
    Hemolysis

    Study Results

    No Results Posted as of May 6, 2023