Clinical trial Recruiting at 1 site Observational Ages Any age to 7 Days

Evaluating the role of end-tidal carbon monoxide in diagnosing and treating ABO hemolytic disease in newborns

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

Run by Women's Hospital School Of Medicine Zhejiang University · NCT05842109 · Data updated 2026-11-12

This study is testing if measuring carbon monoxide levels in the breath can help doctors better diagnose and treat newborns with ABO hemolytic disease.

Quick facts

Study typeObservational
AgesAny age to 7 Days
SexAll
Enrollment112 (estimated)
SponsorWomen's Hospital School Of Medicine Zhejiang University
Academic / other
Locations1 site (Hangzhou)
StatusRecruiting
StartedOctober 31, 2023
Main results expectedOctober 31, 2025
Study endsDecember 31, 2026
Registry record updatedFebruary 5, 2025
Trial IDNCT05842109 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are neonates with gestational ages between 35 and 41 weeks, weighing at least 2500 grams, and diagnosed with hyperbilirubinemia due to ABO incompatibility.

Probably not a fit

Patients with severe congenital malformations, respiratory distress requiring support, or those receiving intensive care in the NICU may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study aims to assess the clinical indicators of neonates with ABO hemolytic disease, focusing on end-tidal carbon monoxide (ETCOc) levels. It compares clinical outcomes between hemolytic and non-hemolytic groups, as well as between neonates treated with intravenous immunoglobulin (IVIG) and those who are not. The study will record various clinical indicators, including total serum bilirubin levels and hemoglobin, to explore the diagnostic and treatment value of ETCOc in this condition. Participants will be neonates with hyperbilirubinemia due to ABO incompatibility, and follow-up will be conducted to monitor their progress.

Why it matters

Potential benefit: If successful, this study could enhance the diagnostic accuracy and treatment strategies for neonates suffering from ABO hemolytic disease.

How similar studies have gone: While the specific use of ETCOc in this context may be novel, similar studies exploring clinical indicators in neonatal hemolytic disease have shown promising results.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Women's hospital School of medicine Zhejiang University
    Hangzhou, China
    Recruiting

Study contacts

  • Principal investigator: Yingying Bao, M.M. — Women's Hospital School Of Medicine Zhejiang University
  • Study coordinator: Yingying Bao, M.M.
  • Email: yingyingbao@zju.edu.cn
  • Phone: 13777834165

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.