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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.
The purpose the research is:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective | Other | Standard of Care for Diagnosis and management of neonatal jaundice + End Tidal Carbon Monoxide measurement value |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| End Tidal Carbon Monoxide Value | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jyotirbala N Ruparel, MD | Contact | 9727465161 | jyotirbala.ruparel@cshs.org |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15231951 | Background | 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. | |
| 24743136 | Background | 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. |
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| ID | Term |
|---|---|
| D007567 | Jaundice, Neonatal |
| ID | Term |
|---|---|
| D051556 | Hyperbilirubinemia, Neonatal |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
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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)
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|
| 6 months |
| Recording of nursing time to perform the test | The time taken by medical personnel to perform and record results will be recorded | 6 months |
| 26802319 | Background | 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. |
| 26394287 | Background | 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. |
| 9917432 | Background | 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. |
| 19255038 | Background | 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. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |