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

NCT07346976 | Recruiting

• 1 other identifier: KY-2025-182
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Hyperbilirubinemia

Outcome Measures

Primary Outcomes (2)

• The ETCOc values of newborns were measured, and the optimal ETCOc threshold values between different time points of the TSB group were obtained.

  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 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)

• The ETCOc values of newborns

  The ETCOc values of newborns were measured, and the optimal ETCOc threshold values between different time points of the TSB group were obtained.

  12 hours, 24 hours, 48 hours and 72 hours after the birth of the newborn

Study Arms (1)

term neonates

EXPERIMENTAL

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.

Device: Erythrocyte Life Span Tester

Interventions

Erythrocyte Life Span Tester DEVICE

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.

term neonates

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborns with gestational age of ≥ 37 weeks and birth weight of ≥ 2.5 kg;
• Newborns delivered by either vaginal delivery or cesarean section and with hospital stay of ≥ 3 days.

You may not qualify if:

• History of second-hand smoke exposure within 24 hours
• Parents smoke or are exposed to second-hand smoke.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

4th Affiliated Hospital, School of Medicine, Zhejiang University

Yiwu, Zhejiang, 322000, China

RECRUITING

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yixiang Wu

CONTACT

+8613600643385; laibujilene@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 16, 2026
• Study Start: December 5, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)