Evaluating the role of end-tidal carbon monoxide in diagnosing and treating ABO hemolytic disease in newborns
Clinical Value of ETCOc in the Diagnosis and Treatment of ABO Hemolytic Disease of the Newborn
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 |
|---|---|
| Enrollment | 112 (estimated) |
| Ages | N/A to 7 Days |
| Sex | All |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou) |
| Trial ID | NCT05842109 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hangzhou
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.