None listed
Conditions
Brief summary
This pilot study intends to compare the effect of two different levels of positive end-expiratory pressure (PEEP) on the respiratory status of premature infants who require continuous positive airway support (CPAP) for the treatment of respiratory distress syndrome. Our hypothesis that there is no difference in the number of apnoea, bradycardia and desaturation episodes, and oxygen requirement when using PEEP 6cmH2O as compared to 8cmH2O.
Interventions
Continuous Positive Airway Pressure (CPAP) at 8cmH2O supplied via Hudson CPAP to an infant who is already using Hudson CPAP for respiratory support. During two seperate five-hour periods on consecutive days, the infant receiving the CPAP pressure of 8cmH2O will have the oxygen requirement, blood oxygen saturation and heart rate recorded by the Neonatal Unit's electronic bedside monitoring system. The hypothesis is that there is no difference in the number of apnoeas, bradycardias, desaturation
Continuous Positive Airway Pressure (CPAP) at 8cmH2O supplied via Hudson CPAP to an infant who is already using Hudson CPAP for respiratory support. During two seperate five-hour periods on consecutive days, the infant receiving the CPAP pressure of 8cmH2O will have the oxygen requirement, blood oxygen saturation and heart rate recorded by the Neonatal Unit's electronic bedside monitoring system. The hypothesis is that there is no difference in the number of apnoeas, bradycardias, desaturation episodes and oxygen requirement between the two CPAP pressures of 8cmH2O and 6cmH2O. As this is a pilot study, there will be no defined washout period as we do not yet have enough data to predict how long it would need to be. The length of the washout period would be one of the things we want to discover from the trial.
Sponsors
Anna Tottman
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
24 Weeks to 30 Weeks
Healthy volunteers
No
Inclusion criteria
Premature infant of less than 30 weeks corrected gestational age, diagnosis of respiratory distress syndrome, ongoing respiratory distress or apnoea of prematurity requiring treatment with CPAP, stable on CPAP for the past 48 hours, no changes to caffeine dose (if used) for 48 hours.
Exclusion criteria
Major congenital of chromosomal abnormality, treatment with doxapram for troublesome apnoea, current post-natal corticosteroid treatment, any contraindication to the use of CPAP
Outcome results
None listed