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
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
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
NCT ID
NCT05475223
First Posted
July 24, 2022
Last Updated
July 26, 2022
Sponsor
Cedars-Sinai Medical Center
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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End Tidal Carbon Monoxide (ETCO): - A Tool to Aid Identification of Neonatal Hemolysis
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