Breath carbon monoxide measurement to help manage newborn jaundice.
Official title: Investigation Into the Dynamic Variations of End-Tidal Carbon Monoxide Concentration (ETCOc) in Neonates Utilizing Non-Dispersive Infrared Spectroscopy and Its Implications for Jaundice Management.
Run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · NCT07346976 · Data updated 2026-11-12
This project tests whether measuring end-tidal carbon monoxide from a newborn's breath in the first three days can help guide jaundice care for full-term babies.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Days to 28 Days |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Yiwu, Zhejiang) |
| Status | Recruiting |
| Started | December 5, 2025 |
| Main results expected | July 1, 2026 |
| Study ends | July 1, 2027 |
| Registry record updated | January 16, 2026 |
| Trial ID | NCT07346976 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Full-term newborns (gestational age ≥37 weeks), birth weight ≥2.5 kg, remaining in hospital for at least three days, and with no recent household smoke exposure are ideal candidates.
✕Probably not a fit
Preterm or low-birth-weight infants, babies discharged before three days, or infants with recent second-hand smoke exposure are unlikely to benefit from the study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study measures end-tidal carbon monoxide concentration (ETCOc) using non-dispersive infrared spectroscopy in newborns during the first three days of life, with readings adjusted for ambient CO levels. Participants are term infants (≥37 weeks gestation, ≥2.5 kg) who remain hospitalized for at least three days and have no household smoke exposure. The trial seeks to define diagnostic ETCOc thresholds stratified by neonatal age at birth and to compare the device's risk range with values reported in the literature. Device reliability and concordance with existing bilirubin risk markers will be evaluated to determine whether ETCOc can be used in jaundice management.
Why it matters
Potential benefit: If successful, this could provide a quick, noninvasive bedside test to identify newborns at higher risk of significant jaundice and reduce the need for blood draws.
How similar studies have gone: Previous research on measuring CO or ETCOc in neonates has shown promise correlating with hemolysis and jaundice risk, but devices, thresholds, and clinical adoption remain variable.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Newborns with gestational age of ≥ 37 weeks and birth weight of ≥ 2.5 kg; 2. Newborns delivered by either vaginal delivery or cesarean section and with hospital stay of ≥ 3 days. Exclusion Criteria: 1. History of second-hand smoke exposure within 24 hours 2. Parents smoke or are exposed to second-hand smoke.
Where it's running
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4th Affiliated Hospital, School of Medicine, Zhejiang University
Yiwu, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Yixiang Wu
- Email: laibujilene@163.com
- Phone: +8613600643385
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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.