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Breath carbon monoxide measurement in jaundiced newborns

Early identification of hemolysis with ETCOc measurement in neonates at risk for severe hyperbilirubinemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN80570289
Enrollment
50
Registered
2018-07-20
Start date
2018-07-09
Completion date
Unknown
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal hyperbilirubinemia (jaundice) Pregnancy and Childbirth Neonatal hyperbilirubinemia

Interventions

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. The

Sponsors

United Italian Trading Corporation (PTE) LTD
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Maternal history of smoking 2. Neonates requiring respiratory support

Design outcomes

Secondary

MeasureTime frame
Linear correlation between ETCOc values and the degree of hemolysis, as assessed using reticulocyte counts

Primary

MeasureTime frame
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

Countries

Singapore

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026