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NCT Number: NCT05842109

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

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.

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Key information

Conditions

ABO Hemolytic Disease of Newborn Hyperbilirubinemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Women's hospital School of medicine Zhejiang University

Hangzhou, China

Location status: Recruiting

Location contact

Yingying Bao

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. concentration of ETCOc (end tidal carbon monoxide)

    Time frame: through study completion, planned to be 1.5 year

    ETCOc in ppm

Secondary outcomes

  1. concentration of bilirubin

    Time frame: through study completion, planned to be 1.5 year

    bilirubin in mg/dl

  2. result of DAT

    Time frame: through study completion, planned to be 1.5 year

    DAT result of positive or negtive

Study contacts

Contact information is provided by the study sponsor or research team.

Chuncai Xu, M.M.

CONTACT

[email protected]

15257168032

Yingying Bao, M.M.

CONTACT

[email protected]

13777834165

Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 3, 2023
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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