None listed
Conditions
Brief summary
The purpose of this clinical investigation is to compare the performance of a flow generator to deliver bubble CPAP (BCPAP) therapy in the Neonatal Intensive Care Unit (NICU) to spontaneously breathing infants requiring respiratory support. The trial objective is to test if the flow generator system is non-inferior to the same therapy delivered using existing systems with respect to measured SpO2 in sub population of neonates who require BCPAP therapy
Interventions
The investigational device (neonatal flow generator) will be used to deliver flow and humidity for bubble continuous airway pressure (BCPAP) therapy to a neonate currently on BCPAP in the NICU. The investigational device will be compared to control device (F&P 950 setup) using un-blinded, 2-sequence, 2-treatment, 4-period, randomised cross-over design. The randomization sequence will be either ABBA or BAAB (A = control, B = investigational device). Each period will last 30-minutes. The flow and
The investigational device (neonatal flow generator) will be used to deliver flow and humidity for bubble continuous airway pressure (BCPAP) therapy to a neonate currently on BCPAP in the NICU. The investigational device will be compared to control device (F&P 950 setup) using un-blinded, 2-sequence, 2-treatment, 4-period, randomised cross-over design. The randomization sequence will be either ABBA or BAAB (A = control, B = investigational device). Each period will last 30-minutes. The flow and pressure setting on the investigation device will be set to match the therapy setting currently used on the neonate. The investigator will change between devices by disconnecting the inspiratory tube from the patient interface and connecting the inspiratory tube of the other device. The remainder of the setup for BCPAP therapy (i.e. patient interface, expiratory tube, bubbler) will remain unchanged when changing between the control and investigational devices.
Sponsors
Fisher & Paykel Healthcare
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
6 Hours to 7 Weeks
Healthy volunteers
No
Inclusion criteria
• Born at GA greater than or equal to 33 weeks • Clinical decision that the baby should continue BCPAP therapy for the next 6 hours • Infant is stable for >4 hours on a BCPAP pressure of 6 cmH2O and 6 L/min with no oxygen requirement, with a respiratory rate of <60 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 BCPAP. • Prenatal asphyxia (Apgar score less than 3 at minute 5, Cord pH less than 7, and cord bicarbonate less than 12) • Infants with notifiable diseases.
Outcome results
None listed