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NCT Number: NCT07346976

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 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.

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Key information

Conditions

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

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

4th Affiliated Hospital, School of Medicine, Zhejiang University

Yiwu, Zhejiang, 322000, China

Location status: Recruiting

Location contact

Yixiang WU

CONTACT

[email protected]

13600643385

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

  2. The ETCOc values of newborns

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yixiang Wu

CONTACT

[email protected]

+8613600643385

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study 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.

Acronym: ETCO

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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