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End Tidal Carbon Monoxide (ETCO): - A Tool to Aid Identification of Neonatal Hemolysis

NCT05475223 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2022-07-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate if adding a noninvasive testing of End Tidal Carbon Monoxide with a FDA approved device will help improve management of jaundice in the Neonates by reducing the number of lab draws, Coombs tests and optimizing the number of phototherapy hours in Neonates who need it.

Eligible subjects will be Term and healthy late preterm newborns born at Cedars-Sinai Medical Center and admitted to well baby nursery from November 2020 onwards.

The primary procedure of measuring an End-Tidal Carbon monoxide in a Newborn is going to be with a soft cannula applied to the Newborn's nose for a few minutes. The whole procedure will take about 15+ 5 minutes.

Subject participation will last approximately 6 months and all subjects will be followed up with one phone call at about 2-4 weeks of age.

Adding ETCO testing to current standard of care might reduce the number of lab draws in a newborn and potentially reduce costs by optimizing the number of phototherapy hours in a Newborn who needs it. Cedars- Sinai Medical Center will not be billing the patients for the End-Tidal Carbon Monoxide measurement for this study.

Conditions

  • End Tidal Carbon Monoxide Excretion as a Diagnostic Tool for Hemolysis in the Newborn
  • Neonatal Jaundice
  • End Tidal Carbon Monoxide

Interventions

DIAGNOSTIC_TEST

End Tidal Carbon Monoxide Value

A noninvasive ETCO value will be obtained by inserting a soft silicon cannula placed in the baby's nostril for a few minutes to measure exhaled end tidal carbon monoxide; a value corrected for ambient ETCO value will be recorded.

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Weeks
Max Age
44 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-29
Primary Completion
2022-12-31
Completion
2022-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05475223 on ClinicalTrials.gov