Clinical trial NCT05475223: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 350
Sex: ALL
Minimum age (years): 35
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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)
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Change in usage of Coombs Test and other Labs Ordered for hemolysis in Neonatal Jaundice
timeFrame: 6 months
Secondary outcomes:
measure: Adding ETCO to diagnostic procedures for hemolysis in neonatal jaundice will help optimize phototherapy
timeFrame: 6 months
measure: Recording of nursing time to perform the test
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
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.
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.
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.