None listed
Conditions
Brief summary
Reduced duration of respiratory support for preterm infants is associated with fewer health issues and improved outcomes. Although nasal continuous positive airway pressure (nCPAP) is currently the most widely used non-invasive ventilation, heated humidified high-flow nasal cannula (HHHFNC) is now used as an alternative. However, there is limited evidence-based data to support its use as standard practice for weaning infants from nCPAP. In this study we will compare the duration of respiratory support needed by preterm infants when weaning from both nCPAP and HHHFNC, and determine the safety and efficacy of both therapies. We will also compare adverse events, nasal trauma (a common complication of nCPAP), feeding practices, nursing acuity, costs and parental satisfaction. The results of this study will be used to define a weaning strategy for preterm infants needing respiratory support and have the potential to change standard practice in neonatal units.
Interventions
Heated Humidified High Flow Nasal Cannula (HHHFNC) therapy. HHHFNC will be delivered at a flow rate of 2L-6L/min, of blended gas/oxygen, using Fisher & Paykel circuits and nasal prongs. HHHFNC prong size to be selected as per the manufacturer's recommendations, with no alterations to be made to the manufacturer's recommended circuit set-up.
1. Infants randomised to HHHFNC will commence on a flow rate of 6L/min.
2. The attending Senior Medical Officer (SMO) will decrease/increase flow rates a
Heated Humidified High Flow Nasal Cannula (HHHFNC) therapy. HHHFNC will be delivered at a flow rate of 2L-6L/min, of blended gas/oxygen, using Fisher & Paykel circuits and nasal prongs. HHHFNC prong size to be selected as per the manufacturer's recommendations, with no alterations to be made to the manufacturer's recommended circuit set-up. 1. Infants randomised to HHHFNC will commence on a flow rate of 6L/min. 2. The attending Senior Medical Officer (SMO) will decrease/increase flow rates at their discretion. These changes will require a documented medical order. Infants will be reviewed at least 24 hourly and flow rates decreased to a minimum flow rate of 2L/min. If SMO deems necessary to increase flow rates, these will not exceed 8L/min in any infant. 3. Infants who are stable on 2L/min, with Fi02 <30% for 24 hours, may cease HHHFNC and be tried in air or on low flow nasal cannula. Trial off HHHFNC is at the discretion of the SMO, and is not mandatory at this time. 4. Infants who satisfy failure criteria whilst receiving HHHFNC at 6L/min will have their flow increased to 8L/min HHHFNC. If continue to meet failure criteria at this time, will be placed on 'rescue' nCPAP at 8cmH20. When these infants once again reach the study inclusion criteria they will be placed back on the HHHFNC arm of the trial. 5. Endpoint of the study will occur at 36 weeks gestational age.
Sponsors
Middlemore Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
49 Hours to 3 Months
Healthy volunteers
No
Inclusion criteria
Preterm infants born at <30 weeks gestational age are eligible. At study entry infants should have at least 48 hours with nCPAP pressure 6cm water, without an oxygen requirement, with a respiratory rate of <60bpm and without significant desaturation or bradycardia events (defined as spontaneous events with oxygen saturation levels <80%, heart rate <100bpm and requiring nursing staff intervention). Infants will be commenced onto the weaning protocol at the discretion of the Neonatologist.
Exclusion criteria
1. Preterm infants off respiratory support for greater than 7 days. 2. Infants with significant congenital heart disease, surgical conditions, chromosomal abnormalities, genetic syndromes or other major congenital malformations.
Outcome results
None listed