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 Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status: Enrolling

Conditions: Neonatal Hyperbilirubinemia

Treatments: Device: Erythrocyte Life Span Tester

Study type: Interventional

Funder types: Other

Identifiers

NCT07346976

KY-2025-182

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

term neonates

Experimental group

Description:

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:

Device: Erythrocyte Life Span Tester