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

NCT ID: NCT07346976

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-05

Study Completion Date

2027-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Neonatal Hyperbilirubinemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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term neonates

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.

Group Type EXPERIMENTAL

Erythrocyte Life Span Tester

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

0 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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4th Affiliated Hospital, School of Medicine, Zhejiang University

Yiwu, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yixiang Wu

Role: CONTACT

+8613600643385

Facility Contacts

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Yixiang WU

Role: primary

13600643385

Other Identifiers

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KY-2025-182

Identifier Type: -

Identifier Source: org_study_id

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