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Recruiting 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

No phase Interventional Neonatal Hyperbilirubinemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erythrocyte Life Span Tester.
Who it may be relevant to
Registry conditions: Neonatal Hyperbilirubinemia. Basic parameters: 0 Days — 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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.

Overview

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

  • Device 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.

Primary outcome measures

  • 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)]
  • The ETCOc values of newborns [Time frame: 12 hours, 24 hours, 48 hours and 72 hours after the birth of the newborn]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

China · 1 center
  • 4th Affiliated Hospital, School of Medicine, Zhejiang University — Yiwu

Identifiers

NCT: NCT07346976 · KY-2025-182

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗