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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-28
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

History of second-hand smoke exposure within 24 hours

Parents smoke or are exposed to second-hand smoke.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: term neonatesExperimental treatment 1 intervention

Trial outcomes

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.

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.

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)
2

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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