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 type | Observational |
|---|---|
| Ages | Any age to 7 Days |
| Sex | All |
| Enrollment | 112 (estimated) |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou) |
| Status | Recruiting |
| Started | October 31, 2023 |
| Main results expected | October 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | February 5, 2025 |
| Trial ID | NCT05842109 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.
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Global registry for hemolytic disease of the fetus and newborn (HDFN)
This project will follow pregnant people at risk for HDFN to see how often their fetuses or newborns develop anemia while receiving standard care.
-
Measuring S100B Protein Levels in Newborns After Intrauterine Blood Transfusions for Fetal Anemia
This study is testing if measuring a specific protein in the blood of newborns who received blood transfusions before birth can help predict the risk of brain problems later on.
-
Nipocalimab treatment for pregnant women at risk of severe fetal anemia
This study is testing if nipocalimab can help pregnant women at risk of having babies with severe anemia due to a past condition, to see if it improves the health of their newborns.
-
Determining safe levels to stop phototherapy for newborn jaundice
This study is testing if stopping light treatment for jaundice in newborns at a lower level is safer and helps prevent a return of high bilirubin levels compared to stopping at a higher level.
-
IVIG given to the fetus during intrauterine transfusion for Rh isoimmunization
This study tests whether giving intravenous immunoglobulin directly to the fetus during intrauterine transfusion helps improve birth blood counts for babies affected by Rh isoimmunization.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.