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

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
End Tidal Carbon Monoxide Value
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for End Tidal Carbon Monoxide Excretion as a Diagnostic Tool for Hemolysis in the Newborn focused on measuring Neonatal Hemolysis, Neonatal Jaundice, ETCO, End Tidal Carbon Monoxide

Eligibility Criteria

35 Weeks - 44 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • male or female with GA > 35 weeks and BW > 2000, post natal age 6 hours to < 6 days of age and meets any one of the following criteria

    • Due for an early discharge
    • Has a TcB or Tsb on or > the 75th % of Bhutani hyperbilirubinemia nomogram
    • Has 2 or more risk factors for neonatal jaundice as specified in the protocol

Exclusion Criteria:

  • babies requiring any kind of respiratory support (O2, CPAP or assisted ventilation) has severe or life threatening congenital anomalies, weighed less than 2000 gms and if their mother has a known history of smoking during 3rd trimester of pregnancy. Also in addition nasal mucosal abrasion or nasal mucosal abnormalities will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Prospective

    Arm Description

    Standard of Care for Diagnosis and management of neonatal jaundice + End Tidal Carbon Monoxide measurement value

    Outcomes

    Primary Outcome Measures

    Change in usage of Coombs Test and other Labs Ordered for hemolysis in Neonatal Jaundice
    We expect a projected change of 10-15% in Coombs Test usage for neonatal jaundice and mean difference of 1 in other labs ordered for hemolysis in neonatal jaundice

    Secondary Outcome Measures

    Adding ETCO to diagnostic procedures for hemolysis in neonatal jaundice will help optimize phototherapy
    On average on readmission at Cedars- Sinai Medical Center a newborn gets 36 +/-10 hours of phototherapy and on birth admission some babies are getting 6 +/- 12 hours of phototherapy. ETCO (End tidal carbon monoxide value) used a function of Total serum bilirubin will help optimize the number of hours of phototherapy.
    Recording of nursing time to perform the test
    The time taken by medical personnel to perform and record results will be recorded

    Full Information

    First Posted
    July 24, 2022
    Last Updated
    July 26, 2022
    Sponsor
    Cedars-Sinai Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05475223
    Brief Title
    End Tidal Carbon Monoxide (ETCO): - A Tool to Aid Identification of Neonatal Hemolysis
    Official Title
    End Tidal Carbon Monoxide (ETCO) : A Tool to Aid Identification of Neonatal Hemolysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 29, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cedars-Sinai Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed Description
    The purpose the research is: Whether near simultaneous measurements of Total Serum bilirubin (Tsb) & End-Tidal Carbon Monoxide (End-Tidal Carbon monoxide as a function of bilirubin) will help identify hyperbilirubinemia accurately and easily This has been shown in a single center study. Whether near simultaneous measurement of Total serum bilirubin & End Tidal Carbon Monoxide is more accurate and less costly in overall management of Neonatal Hyperbilirubinemia Eligible infants would be male or female with GA > 35 weeks and BW > 2000, post natal age 6 hours to < 6 days of age and meets any one of the following criteria Due for an early discharge Has a Transcutaneous bilirubin or a Total serum bilirubin on or > the 75th % of Bhutani hyperbilirubinemia nomogram Has 2 or more risk factors for neonatal jaundice as specified in the protocol The study includes 388 patients in each arm - ~ 776 total newborn admissions The total study duration is: 6 months Methods: a retrospective group (Standard of Care) will be compared with a prospective Group (Standard of care + End-Tidal Carbon monoxide). Informed Consent will be obtained before the subject is recruited in the prospective group. A phone call will be made to each subject in the prospective group at 2-4 weeks of age post birth hospitalization. This is a minimally risk study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End Tidal Carbon Monoxide Excretion as a Diagnostic Tool for Hemolysis in the Newborn, Neonatal Jaundice, End Tidal Carbon Monoxide
    Keywords
    Neonatal Hemolysis, Neonatal Jaundice, ETCO, End Tidal Carbon Monoxide

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Retrospective review of subjects for Standard of Care for Neonatal jaundice diagnosis and management (SOC) will be compared with a prospective group of subjects with Standard of care for Neonatal jaundice for diagnosis and management + End Tidal Carbon Monoxide management (ETCO)
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prospective
    Arm Type
    Other
    Arm Description
    Standard of Care for Diagnosis and management of neonatal jaundice + End Tidal Carbon Monoxide measurement value
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    End Tidal Carbon Monoxide Value
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in usage of Coombs Test and other Labs Ordered for hemolysis in Neonatal Jaundice
    Description
    We expect a projected change of 10-15% in Coombs Test usage for neonatal jaundice and mean difference of 1 in other labs ordered for hemolysis in neonatal jaundice
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Adding ETCO to diagnostic procedures for hemolysis in neonatal jaundice will help optimize phototherapy
    Description
    On average on readmission at Cedars- Sinai Medical Center a newborn gets 36 +/-10 hours of phototherapy and on birth admission some babies are getting 6 +/- 12 hours of phototherapy. ETCO (End tidal carbon monoxide value) used a function of Total serum bilirubin will help optimize the number of hours of phototherapy.
    Time Frame
    6 months
    Title
    Recording of nursing time to perform the test
    Description
    The time taken by medical personnel to perform and record results will be recorded
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Weeks
    Maximum Age & Unit of Time
    44 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: male or female with GA > 35 weeks and BW > 2000, post natal age 6 hours to < 6 days of age and meets any one of the following criteria Due for an early discharge Has a TcB or Tsb on or > the 75th % of Bhutani hyperbilirubinemia nomogram Has 2 or more risk factors for neonatal jaundice as specified in the protocol Exclusion Criteria: babies requiring any kind of respiratory support (O2, CPAP or assisted ventilation) has severe or life threatening congenital anomalies, weighed less than 2000 gms and if their mother has a known history of smoking during 3rd trimester of pregnancy. Also in addition nasal mucosal abrasion or nasal mucosal abnormalities will be excluded.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jyotirbala N Ruparel, MD
    Phone
    9727465161
    Email
    jyotirbala.ruparel@cshs.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    15231951
    Citation
    American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004 Jul;114(1):297-316. doi: 10.1542/peds.114.1.297. Erratum In: Pediatrics. 2004 Oct;114(4):1138.
    Results Reference
    background
    PubMed Identifier
    24743136
    Citation
    Tidmarsh GF, Wong RJ, Stevenson DK. End-tidal carbon monoxide and hemolysis. J Perinatol. 2014 Aug;34(8):577-81. doi: 10.1038/jp.2014.66. Epub 2014 Apr 17.
    Results Reference
    background
    PubMed Identifier
    26802319
    Citation
    Bhutani VK, Srinivas S, Castillo Cuadrado ME, Aby JL, Wong RJ, Stevenson DK. Identification of neonatal haemolysis: an approach to predischarge management of neonatal hyperbilirubinemia. Acta Paediatr. 2016 May;105(5):e189-94. doi: 10.1111/apa.13341. Epub 2016 Feb 29.
    Results Reference
    background
    PubMed Identifier
    26394287
    Citation
    Christensen RD, Malleske DT, Lambert DK, Baer VL, Prchal JT, Denson LE, Gerday E, Weaver Lewis KA, Shepherd JG. Measuring End-Tidal Carbon Monoxide of Jaundiced Neonates in the Birth Hospital to Identify Those with Hemolysis. Neonatology. 2016;109(1):1-5. doi: 10.1159/000438482. Epub 2015 Sep 23.
    Results Reference
    background
    PubMed Identifier
    9917432
    Citation
    Bhutani VK, Johnson L, Sivieri EM. Predictive ability of a predischarge hour-specific serum bilirubin for subsequent significant hyperbilirubinemia in healthy term and near-term newborns. Pediatrics. 1999 Jan;103(1):6-14. doi: 10.1542/peds.103.1.6.
    Results Reference
    background
    PubMed Identifier
    19255038
    Citation
    Kuzniewicz M, Newman TB. Interaction of hemolysis and hyperbilirubinemia on neurodevelopmental outcomes in the collaborative perinatal project. Pediatrics. 2009 Mar;123(3):1045-50. doi: 10.1542/peds.2007-3413.
    Results Reference
    background

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