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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

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07346976
Acronym
ETCO
Enrollment
100
Registered
2026-01-16
Start date
2025-12-05
Completion date
2027-07-01
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Hyperbilirubinemia

Brief 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.

Interventions

DEVICEErythrocyte 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.

Sponsors

The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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 newborns12 hours, 24 hours, 48 hours and 72 hours after the birth of the newbornThe ETCOc values of newborns were measured, and the optimal ETCOc threshold values between different time points of the TSB group were obtained.

Countries

China

Contacts

CONTACTYixiang Wu
laibujilene@163.com+8613600643385

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026