None listed
Conditions
Brief summary
Apnoea, a pause in respiration, reflects the immaturity of a preterm infant’s respiratory control and is the major contributor to requiring protracted respiratory support, mostly spent on non-invasive forms of support which is reliant on an adequate respiratory drive and airway patency, at a time when both are prone to failure. Despite current administration of therapies to reduce apnoea burden, including non-invasive respiratory support and caffeine, bedside staff are still often required to react urgently to apnoeic events by providing tactile stimuli to re-establish respiratory efforts. Such an approach to management of apnoeic events makes adverse consequences of apnoea (hypoxia and/or bradycardia) in preterm infants inevitable. The ARIA study uses a crossover study design to investigate whether targeted auditory stimulus applied opportunistically soon after the onset of a respiratory pause in preterm infants born at <30 weeks gestation has an effect on shortening apnoea duration and mitigating the adverse apnoea-associated physiological consequences, when compared to standard care. The auditory stimuli examined in the ARIA study includes the mother's voice (attenuated), and a non-vocal sound. The primary outcome measure of the ARIA study is the frequency of apnoeic events lasting >= 5 seconds (per hour).
Interventions
During the intervention epochs, infants admitted to the neonatal intensive care unit and receiving non-invasive respiratory support will be monitored with beside cardiorespiratory and capsule pneumography monitor. When a respiratory pause lasting at least 3s is detected by the capsule pneumography monitor, the intervention (sound stimuli) will be delivered at a sound pressure of 55-65dB for a period of 10s using a wireless waterproof speaker placed in the infant’s humidicrib. If a respiratory pa
During the intervention epochs, infants admitted to the neonatal intensive care unit and receiving non-invasive respiratory support will be monitored with beside cardiorespiratory and capsule pneumography monitor. When a respiratory pause lasting at least 3s is detected by the capsule pneumography monitor, the intervention (sound stimuli) will be delivered at a sound pressure of 55-65dB for a period of 10s using a wireless waterproof speaker placed in the infant’s humidicrib. If a respiratory pause last beyond the 10s stimuli, no additional stimuli will be delivered until respiratory effort is re-established. If a second respiratory pause occur when the 10s stimuli is being delivered, no second 10s stimuli will be delivered for the second respiratory pause. Infants will be exposed to the Mother’s voice (arm 1) for 4h, and the non-vocal sound (arm 2) for 4h. As this is a crossover study design, consisting of two 4h intervention and two 4h control epochs in randomised sequence, with a 15 min washout period between epochs (i.e. infants will be exposed to both interventions, and each study will last a total of 16 hours). Infants admitted to the neonatal intensive care unit are continuously monitored by nurses who responses to standard clinical alarms/concerns. Data will be recorded continuously including time when intervention is delivered, and any alarms, allowing us to monitor adherence to the intervention.
Sponsors
University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 4 Months
Healthy volunteers
No
Inclusion criteria
• Birth gestation of <30 weeks • Chronological age of <4months • Supported with non-invasive respiratory support, namely CPAP, or HFNC • Agreement of treating clinician that the infant is suitable for inclusion in the study
Exclusion criteria
• Infant considered to be too unstable to be exposed to additional auditory stimuli. • Escalation in respiratory support mode being contemplated in the next 24 hours.
Outcome results
None listed