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
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Phase
Not applicable
Started
2025-12-05
Last updated
2026-01-16
Condition(s) studied
Neonatal Hyperbilirubinemia
Investigational drug(s) / intervention(s)
Erythrocyte Life Span Tester
Erythrocyte Life Span Tester: The non-dispersive infrared spectroscopy technique was employed to measure the end-tidal carbon monoxide (ETCOc) levels in newborns at intervals of 12, 24, 48, and 72 hours post-birth.
Study summary
The objective of this study is to ascertain the diagnostic threshold of end-tidal carbon monoxide (ETCOc, adjusted for ambient CO levels) within the first three days postpartum, stratified by neonatal age at birth. Additionally, the study aims to evaluate the concordance of the risk range of ETCOc, as measured by non-dispersive infrared spectroscopy, with existing literature, and to assess the reliability of this technology in the management of neonatal hyperbilirubinemia.
Eligibility
Sex
ALL
Min age
0 Days
Max age
28 Days
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
The ETCOc values of newborns were measured, and the optimal ETCOc threshold values between different time points of the TSB group were obtained. — The non-dispersive infrared spectroscopy technique was used to detect ETCOc in newborns at 12 hours, 24 hours, 48 hours and 72 hours after birth (the ETCOc detection should be completed within 4 hours at each time point) Establish an ETCOc diagnostic threshold for assessing the risk of hyperbilirubinemia in the early postnatal period based on the infant's age at birth. Determine the reliability and repeatability of ETCOc detection using non-dispersive infrared spectroscopy technology.Compare the concentrations of ETCOc between different groups and employ the ROC curve method to ascertain the optimal cut-off values of ETCOc at various time points across the TSB groups.
The ETCOc values of newborns — 12 hours, 24 hours, 48 hours and 72 hours after the birth of the newborn The ETCOc values of newborns were measured, and the optimal ETCOc threshold values between different time points of the TSB group were obtained.
Trial sites (1)
Facility
City
Region
Status
4th Affiliated Hospital, School of Medicine, Zhejiang University
Yiwu
Zhejiang
Recruiting
More The Fourth Affiliated Hospital of Zhejiang University School of Medicine trials in China
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