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

Neonatal Jaundice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05475223
• Other study ID #: STUDY00000491
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 29, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: Cedars-Sinai Medical Center
• Contact: Jyotirbala N Ruparel, MD
• Phone: 9727465161
• Email: jyotirbala.ruparel[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Weeks to 44 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Hemolysis
• Jaundice
• Jaundice, Neonatal
• Neonatal Jaundice

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

References & Publications (6)

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. Erratum in: Pediatrics. 2004 Oct;114(4):1138. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	6 months
Secondary	Recording of nursing time to perform the test	The time taken by medical personnel to perform and record results will be recorded	6 months