A simple breath test, the CoSense® ETCOc Monitor provides early and accurate measurement of hemolysis and neurotoxic risk that can lead to hemolytic hyperbilirubinemia (HB) and kernicterus.
AAP Guideline: “ETCOc is the only test that can confirm the presence or absence of hemolysis and measure the rate of bilirubin production.”
Most babies readmitted for hyperbilirubinemia (HB) are considered low risk at the time of discharge. Universal testing with the non-invasive CoSense® ETCOc monitor before discharge identifies babies with hemolytic conditions who may be at high risk of neurotoxicity.
AAP Guideline: Lower gestational age and hemolytic disease are risk factors for developing significant hyperbilirubinemia and for bilirubin neurotoxicity.
Identify and quantify hemolysis EARLY, provide the necessary treatment, and send them home safe.
In less than 5 minutes, the CoSense® ETCOc Monitor detects the rate of hemolysis through non-invasive ETCOc testing of a newborn’s breath to accurately detect and measure the overproduction of unconjugated bilirubin and provide clear guidance for jaundice management.
Excess bilirubin accumulates in newborns for three reasons:
Prior to ETCOc tests, increased production of neurotoxic unconjugated bilirubin was difficult to detect until symptoms were evident, putting newborns at elevated risk for kernicterus and requiring immediate phototherapy.
Adverse neurodevelopmental outcomes from jaundice may include Kernicterus (KI), Low IQ, auditory anomalies, and respiratory failure.
KI is a life-threatening condition caused by Bilirubin toxicity to parts of the brain. Short hospital stays contribute to KI cases as newborns are discharged at 48-72 hours after birth while TsB peaks at 3-5 days of age, making bilirubin management an outpatient problem. Other risk factors include the failure to check bilirubin or diagnose a hemolytic condition in jaundiced infants in first 24 hours and the failure to recognize risk factors.
A common protocol is to perform one or more transcutaneous bilirubin (TCB) tests on every baby within the first 24 hours. When jaundice is suspected, an invasive total serum bilirubin (TSB) test is required.
However, these blood tests can be unreliable in identifying cases of over unconjugated bilirubin production because they reflect all bilirubin in the blood. A high TSB/TCB level could indicate elevated production, decreased conjugation of bilirubin in the liver, or decreased excretion of conjugated bilirubin. Thus, TSB/TCB testing alone is not sufficient for Jaundice management.
We cannot improve what we cannot measure.
“The test most deserving of the designation “gold standard” is ETCOc measurement. Moreover, this method is the one we judge best fulfills the AAP 2022 recommendation to ‘identify neonates with hemolysis from any cause’.(Christensen RD et al. J Perinatol. 2023 Jul 19.)
According to AAP Guidelines, “ETCOc levels can confirm the presence or absence of hemolysis, and measurement of ETCOc is the only clinical test that provides a direct measurement of the rate of bilirubin production…”
An elevated level of exhaled ETCOc is a clear indication of active hemolysis that can be measured and monitored non-invasively.
Commonly used invasive blood tests to determine if a baby is hemolyzing include coombs/DAT, CBC, Reticulocyte count, peripheral smear, Type RH, G6PD. These tests either indirectly measure bilirubin production or attempt to identify a cause of hemolysis and are often inaccurate or unable to diagnose hemolytic conditions.
According to peer-reviewed evidence from Ruparel, Elsaie, Schutzman, and Christensen, DAT testing is inadequate. Positive patients typically receive unnecessary phototherapy while DAT negative patients are often sent home with an undiagnosed hemolytic condition.
Published data show that ETCOc testing provides a more accurate measure of hemolysis than blood testing. More than a dozen clinical studies have validated the ability of the CoSense® ETCOc Monitor to detect the rate of hemolysis in newborns. As a result, the Academy of American Pediatrics (AAP) recommends ETCOc testing to measure bilirubin production rates in newborns.
Dr. Bahr is a neonatologist and Assistant Professor of Pediatrics at Intermountain Health and the University of Utah. Dr. Bahr completed medical school at the University of Iowa and his pediatrics residency at Phoenix Children's Hospital. He completed his fellowship in neonatology and neonatal hematology with Drs. Robert Christensen and Robin Ohls at the University of Utah in Salt Lake City, UT. Dr. Bahr’s research and clinical interests are in hematologic disorders of neonates. He has published extensive clinical and translational research in areas such as (1) the management and diagnosis of neonates with hyperbilirubinemia; (2) preventing, detecting, and managing iron deficiency in preterm neonates; and (3) improving neonatal transfusion practices.
Dr. Anthony E. Burgos, MD, MPH is the Co-Founder and President of Bilitool, Inc., the most widely used website for the management of hyperbilirubinemia in newborns. He is the Co-Founder and former Managing Director of the Better Outcomes for Newborns (BORN) research network of the Academic Pediatric Association. He is currently an Associate Professor of Clinical Science and Health Systems Science at the Kaiser Permanente Bernard J. Tyson School of Medicine. He is widely published in the areas of newborn jaundice and newborn standards of care. He is committed to identifying and integrating innovation, building consensus, and improving practice standards to make a measurable difference in healthcare.
Dr. Christensen, a pro bono advisor, is the Director of Neonatal Research at Intermountain Healthcare and Director of the Intermountain Healthcare Clinical Neonatology Program for the northern region, where the majority of his research work is focused on observational and interventional clinical studies of neonatal clinical hematology and transfusion medicine. Dr. Christensen held positions including Professor of Pediatrics at the University of Utah School of Medicine, the University of Florida College of Medicine, and the University of South Florida College of Medicine, and was Physician-in-Chief at All Children’s Hospital in St. Petersburg, Florida. He has been a member of the NIH National Heart, Lung and Blood Institute, NIH National Institute of Child Health and Human Development, and National Foundation March of Dimes, was on the executive committee of Thrasher Research Fund, and was sub-committee chair of the American Academy of Pediatrics. He has authored over 300 publications.
Dr. Schutzman is a neonatologist at Jefferson Einstein Medical Center in Philadelphia. Dr. Schutzman completed medical school, a Pediatric residency, and a fellowship in Neonatal-Perinatal Medicine at Jefferson Medical College. While his career has primarily been clinical in nature, he has published on multiple topics relevant to newborns. Most recently, he has focused his research on hyperbilirubinemia of the newborn and its management.
Dr. David K. Stevenson, MD, is the Harold K. Faber Professor of Pediatrics and has made many impactful contributions to the field of pediatrics. As a neonatologist, his research has focused primarily on neonatal jaundice, with special expertise in carbon monoxide detection for estimating total bilirubin production, and more recently on the causes of preterm birth and its prevention. He has held numerous leadership roles at Stanford University School of Medicine, including Vice Dean and Senior Associate Dean for Academic Affairs, Senior Associate Dean for Maternal & Child Health, Co-Director of the Stanford Maternal & Child Health Research Institute, Co-Director of the Metabolic Health Center, and Principal Investigator for the March of Dimes Prematurity Research Center at Stanford University. Dr. Stevenson has received many awards, including the Virginia Apgar Award, the highest award in Perinatal Pediatrics, the Joseph W. St. Geme, Jr. Leadership Award from the Federation of Pediatric Organizations, the Jonas Salk Award for Leadership in Prematurity Prevention from the March of Dimes Foundation, and the John Howland Medal and Award, the highest award given by the American Pediatric Society. He has served as the President of the American Pediatric Society. In recognition of his achievements, Dr. Stevenson is a member of the National Academy of Medicine.
