Plain English Summary
Background and study aims
We are carrying out a study to measure breath carbon monoxide concentration in newborn infants who either have neonatal jaundice (hyperbilirubinemia) or are at risk for significant jaundice, a condition caused by excessive accumulation of a yellow pigment called bilirubin. High breath carbon monoxide concentration indicates increased breakdown of red blood cells (hemolysis), which is associated with increased risk of significant jaundice and subsequent brain damage. Phototherapy is required to eliminate significant jaundice, as infants with severe jaundice are at risk of permanent brain damage with life-long hearing impairment and cerebral palsy. Early identification of this helps with the timely initiation of phototherapy and to minimise the risk of brain damage. Our goal is to determine whether high breath carbon monoxide concentration is predictive of significant jaundice.
Who can participate?
We have planned to recruit 50 newborn infants born at 35 weeks of gestation or more with a birth weight of 2000 g or more, who are either jaundiced or at risk of significant jaundice.
What does the study involve?
After written consent from parents, infants will have two measurements of breath carbon monoxide concentration measurements 12-24 hours apart. All infants will have blood tests for serum bilirubin every 12-24 hours as decided by the treating physician. All infants with jaundice needing phototherapy will have full blood counts to assess for anemia and hemolysis as in usual treatment. Similarly, infants with blood group incompatibility (mother has blood group O and baby has blood group A or B) will have additional tests for antibodies.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part; however, there should be benefits to infants in future through improving neonatal jaundice management. Infants with high breath carbon monoxide levels will be monitored more closely for development of jaundice and early initiation of phototherapy. Infants with lower breath carbon monoxide levels can be discharged early from the hospital, therefore reducing the number of investigations. There are no known risks to participants taking part in this study.
Where is the study run from?
The study will be conducted at KK Women’s and Children’s Hospital in Singapore.
When is study starting and how long is it expected to run for?
March 2017 to December 2018. Participants will be enrolled on the study for a period of 6 months.
Who is funding the study?
The CoSense device (Capnia,Inc, Palo Alto, CA) used to measure breath carbon monoxide CoSense (Capnia,Inc, Palo Alto, CA) is being loaned to us by United Italian Trading Corporation (PTE) LTD, Singapore for the purpose of this study. Additionally, they have provided disposable nasal tubes for taking breath samples. The rest of the cost will be funded by research funds from the Department of Neonatology, KK Women’s and Children’s Hospital.
Who is the main contact?
Dr Ashwani Bhatia
ashwani.bhatia@kkh.com.sg
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2017/2734
Study information
Scientific title
Early identification of hemolysis with ETCOc measurement in neonates at risk for severe hyperbilirubinemia
Acronym
Study hypothesis
Physiological jaundice (hyperbilirubinemia) is common among newborns in the first week of life and requires monitoring. Early onset, rapidly rising or severe hyperbilirubinemia in neonates is a risk factor for neurotoxicity, especially if due to hemolysis. Bedside measurement of high breath end-tidal monoxide concentration (ETCOc) using a CoSense monitor in jaundiced neonates can provide evidence of increased hemolysis and will prove helpful in closer monitoring and early initiation of intensive phototherapy, and possibly avert exchange transfusion.
Ethics approval
Centralised Institutional Review Board (CIRB), Singapore, 03/05/2018, CIRB Ref:2017/2734
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Neonatal hyperbilirubinemia (jaundice)
Intervention
After written consent from parents, infants will have two measurements of breath carbon monoxide concentration, the first within 12-24 hours of enrolment and the second 12-24 hours following this. These measurements will be taken using a portable CoSense device. All infants with jaundice requiring phototherapy will be tested for full blood counts and reticulocyte count to assess for anemia and hemolysis as per routine management. Similarly, infants with blood group incompatibility (mother has blood group O and baby has blood group A or B) will have additional tests for antibodies.
Intervention type
Device
Phase
Drug names
Primary outcome measure
1. ETCOc (Corrected end-tidal carbon monoxide) values, measured with a CoSense capnometer device. Two measurements will be taken, the first 12-24 hours after recruitment and the second 12-24 following the first measurement.
The following blood test measurements will be taken at the time of admission or later, as per the treating physician's discretion, and will be completed as per routine laboratory investigations:
2. Serum bilirubin
3. Blood counts
4. Reticulocyte counts
5. G6PD status
6. Blood group of mother and baby
7. Antibody titres
8. Coombs test results
Secondary outcome measures
Linear correlation between ETCOc values and the degree of hemolysis, as assessed using reticulocyte counts
Overall trial start date
07/03/2017
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Born or admitted in KK Women's and Children's Hospital
2. Gestational age of 35 weeks or more
3. Birth weight of 2000 g or more
4. Presence of jaundice and requiring phototherapy or presence of blood group incompatibility/G6PD deficiency
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Maternal history of smoking
2. Neonates requiring respiratory support
Recruitment start date
09/07/2018
Recruitment end date
22/11/2018
Locations
Countries of recruitment
Singapore
Trial participating centre
KK Women's and Children's Hospital
100 Bukit Timah Road, Singapore-229899
229899
Singapore
Funders
Funder type
Not defined
Funder name
Department of Nepnatology, KK Women's and Children's Hospital, Singapore
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication plan will be made after the final results are available.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list