Using exhaled carbon monoxide to guide modified care for newborn hemolysis causing severe jaundice
Official title: Modified Diagnosis and Treatment of Neonatal Hemolysis Incorporated With ETCOc Measurement in Severe Neonatal Hyperbilirubinemia Management
Run by Women's Hospital School Of Medicine Zhejiang University · NCT06832800 · Data updated 2026-11-12
This trial will test whether adding a bedside exhaled-carbon monoxide (ETCOc) measurement to a modified diagnosis and treatment plan can help prevent brain damage in newborns with severe hyperbilirubinemia.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 4 Hours to 28 Days |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou) |
| Status | Recruiting |
| Started | July 21, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT06832800 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Term or near-term infants (gestational age 35+0 to 41+6 weeks) with birth weight ≥2500 g who have severe neonatal hyperbilirubinemia (TSB ≥20 mg/dL or within 2 mg/dL of the exchange transfusion threshold) are the intended candidates.
✕Probably not a fit
Infants with confirmed congenital metabolic diseases, chromosomal or genetic disorders, severe malformations, or those born before 35 weeks or under 2500 g are unlikely to be eligible or receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional early-phase study compares a modified diagnosis-and-treatment (MDT) approach incorporating noninvasive ETCOc measurements to current standard management for newborns with severe hyperbilirubinemia. Eligible infants receive either MDT guided by ETCOc or the control management, with monitoring during hospitalization and follow-up to one year. Researchers will record clinical outcomes, the occurrence of brain injury before discharge and at one year, and the frequency of cranial MRI abnormalities detected before age one. The primary focus is whether ETCOc-guided MDT reduces the incidence of bilirubin-related brain damage compared with current management.
Why it matters
Potential benefit: If successful, this approach could reduce the risk of bilirubin-related brain injury by improving early detection of hemolysis and guiding treatment decisions.
How similar studies have gone: Prior research has shown ETCOc can noninvasively indicate hemolysis and correlate with bilirubin burden, but ETCOc-guided modified treatment to prevent neonatal brain injury remains relatively novel and not yet widely proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion Criteria: Infants with gestational age of 35(+0) to 41(+6) weeks and birth weight ≥ 2500 grams * Infants with severe neonatal hyperbilirubinemia, including those whose serum total * bilirubin (TSB) levels reach above 20 mg/dL or whose TSB levels at any time reach within 2 mg/dL of the exchange transfusion threshold (i.e., TSB \> (threshold - 2) mg/dL). Exclusion Criteria: * Infants with definite congenital genetic metabolic diseases, chromosomal or genetic disorders, or severe malformations.
Where it's running
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Women's Hospital School of Medicine Zhejiang University
Hangzhou, China Recruiting
Study contacts
- Principal investigator: Yingying Bao, Doctor — Women's Hospital, Zhejiang University School of Medicine
- Study coordinator: YIngying B
- Email: yingyingbao@zju.edu.cn
- Phone: 086-13777834165
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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.