COSTA
Research type
Research Study
Full title
Carbon diOxide monitoring during neonatal STAbilisation at delivery (COSTA)
IRAS ID
291372
Contact name
Prakash KannanLoganathan
Contact email
Sponsor organisation
South Tees Hospitals NHS FT
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
Research Summary
Babies born prematurely sometimes require breathing support at the time of birth. This support is provided in the form of air-oxygen, delivered by a pressure limited device (positive pressure) using a face mask or placing a plastic tube in the baby’s airway. Applying positive pressure is the current standard of care. Measuring carbon dioxide (CO2) coming out of babies’ lungs, may tell us whether babies are receiving adequate breathing support or not. It could also guide clinicians about how much pressure to use therefore reducing the chance of causing lung damage. Currently there are only limited studies using CO2 at birth. The aim of this study is to understand whether we could use CO2 measurements when we are providing breathing support to preterm babies and if this might be beneficial for these babies.
This study would involve more than 100 preterm babies (born before 32 weeks’ gestation) who need breathing support at the time of birth. All babies would receive the current standard of care (no change in current practice), which includes use of the pulse oximeter. Additionally, a small device will be attached to the usual equipment to measure CO2 levels to all premature babies receiving support. Clinicians will not be able to see the CO2 values. We will continue to measure CO2 until the baby is admitted to the neonatal unit. We will collect certain maternal and neonatal clinical details until the baby is discharged home from hospital records. No personal identification information will be collected. Data will be safely stored in research laptop. This study was discussed with maternity focused patients and public group and received positive feedback.
Summary of results
We have shown that exhaled Carbon dioxide (ECO2) measurement during preterm stabilisation is feasible and could provide potentially useful data. We also showed that the rise in ECO2 could be an early marker of successful stabilisation in preterm infants. We provided trends for ECO2 in preterm infants needing stabilisation during the first 10 minutes of life. ECO2 appeared earlier than valid pulse rate, oxygen saturation and could be one of the early indicators for effective stabilisation in preterm infants.
REC name
West of Scotland REC 4
REC reference
21/WS/0019
Date of REC Opinion
1 Mar 2021
REC opinion
Further Information Favourable Opinion