Breath carbon monoxide measurement to help manage newborn jaundice.
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine Academic / other |
| Locations | 1 site (Yiwu, Zhejiang) |
| Trial ID | NCT07346976 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Yiwu, Zhejiang
- 4th Affiliated Hospital, School of Medicine, Zhejiang University — Yiwu, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Yixiang Wu
- Email: laibujilene@163.com
- Phone: +8613600643385
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.