None listed
Conditions
Brief summary
The purpose of this clinical investigation is to compare the performance of a neonatal flow generator device (a new integrated flow source, oxygen blender, and heated-humidification system) to deliver variable-flow CPAP therapy in the Neonatal Intensive Care Unit (NICU) to spontaneously breathing infants requiring respiratory support. The trial objective will be to collect data to demonstrate that variable-flow CPAP delivered using the neonatal flow generator is non-inferior to the same therapy delivered using existing systems (SLE1000 or SLE6000) in a sub-population in the NICU.
Interventions
The investigational device (neonatal flow generator) will be used to deliver variable-flow CPAP to neonates who are already on variable-flow CPAP with the hospitals standard system (SLE1000 or SLE6000) in the NICU.
The neonatal flow generator is an integrated air source (blower) and humidifier with an integrated oxygen blender and sensor, and is more portable compared to the SLE1000. The neonatal flow generator has a number of features to improve patient monitoring and safety, and improve usabi
The investigational device (neonatal flow generator) will be used to deliver variable-flow CPAP to neonates who are already on variable-flow CPAP with the hospitals standard system (SLE1000 or SLE6000) in the NICU. The neonatal flow generator is an integrated air source (blower) and humidifier with an integrated oxygen blender and sensor, and is more portable compared to the SLE1000. The neonatal flow generator has a number of features to improve patient monitoring and safety, and improve usability in the NICU. To minimize disturbance, all patients receive the sequence of treatment RTR over three periods (Reference ‘R’: variable-flow CPAP via standard hospital system, SLE1000 or SLE6000; Treatment ‘T’: variable-flow CPAP via the neonatal flow generator device). That is, the patients will be observed on the standard variable-flow CPAP therapy for 30 minutes to confirm that they are stable, followed by 60 minutes of recorded observation if stable, then the treatment will be swapped to T for 90 minutes, and then the patient is placed back on standard variable-flow CPAP therapy for a final 90 minutes of observation. During each 90-minute observation period, the last 60 minutes is recorded observation. In total, the patients in this study will be under observation in the study for 4.5 hours (with a total of 3 hours being recorded observation). The investigator will set the pressure of the investigational device to match the pressure of the standard device. The investigator will swap the patients between the devices by changing the patient interface in conjunction with the applicable device. The new device delivers the same therapy as the standard device and will use the same pressure settings, therefore the therapy remains unchanged. An external pressure logger will be used to measure and confirm the pressure delivered by the investigational device.
Sponsors
Fisher & Paykel Healthcare
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
28 Weeks to 200 Days
Healthy volunteers
No
Inclusion criteria
• Born at GA equal to or greater than 28 weeks • Clinical decision that the baby should continue variable-flow CPAP therapy for the next 6 hours • Infant is stable for >3 hours before 1 hour observation period on a variable-flow CPAP pressure between 4 and 10 cmH2O with FiO2 less than or equal to 0.3 oxygen requirement, with a respiratory rate of <70 breaths/min and without significant desaturation or bradycardia events (defined at spontaneous events with oxygen saturation levels < 80%, heart rate <100 beats/min and requiring nursing intervention). • Infants will be discussed with the attending neonatologist as to their suitability relative to the study protocol on the morning ward round, and the ultimate discretion remains at all times with the neonatologist responsible for the infant’s care.
Exclusion criteria
• Infants with congenital abnormalities, suspected chromosomal abnormalities or other conditions which would exclude the use of variable-flow CPAP. • Prenatal asphyxia (Apgar score less than 5 at minute 5, Cord pH less than 7, and Lactate > 6) • Infants with notifiable diseases.
Outcome results
None listed