None listed
Conditions
Brief summary
Each year about 15,000 newborn Australian infants are admitted to hospital with respiratory distress and 2,500-3,000 are transferred to a larger tertiary hospital. The use and popularity of high-flow nasal cannulae to treat newborn infants is increasing. Anecdotally, HFNC is an easy to use therapy that has been used in a variety of clinical setting with success. Due to its simplicity and potential benefits, HFNC may be an ideal therapy for non-tertiary special care nurseries, and may reduce the need to transfer babies to tertiary centres. It is imperative to undertake a high-quality trial to assess the safety and efficacy of HFNC in the non-tertiary setting. This trial will be undertaken in 6-8 non-tertiary SCNs in NSW and Victoria.
Interventions
Infants randomised to the intervention (High FlowNasal Cannula) group will be managed as follows:
*Receive HFNC via the Fisher & Paykel ‘Optiflow’ system, using heated and humidified gases.
*A prong size will be chosen that fits comfortably in the infant’s nares without occluding them.
*HFNC will be commenced at 6L/min for infants weighing <2000 g and 7L/min for infants weighing greater than or equal to 2000 g, and will not be increased. These flow rates were decided upon using the current best
Infants randomised to the intervention (High FlowNasal Cannula) group will be managed as follows: *Receive HFNC via the Fisher & Paykel ‘Optiflow’ system, using heated and humidified gases. *A prong size will be chosen that fits comfortably in the infant’s nares without occluding them. *HFNC will be commenced at 6L/min for infants weighing <2000 g and 7L/min for infants weighing greater than or equal to 2000 g, and will not be increased. These flow rates were decided upon using the current best evidence, known practice, and expert opinion, balancing the need for safety against efficacy. *Inspired oxygen concentration will be adjusted in order to maintain SpO2 at 90-95%. Flow rate will be weaned (in decrements of 1 L/min) to a minimum of 4 L/min. A detailed Clinical Guide will provide guidance on weaning and timing of cessation; the Guide will ensure treatment is tailored to the infant’s clinical condition and anticipated course of illness. *If the infant is weaned off HFNC, but then redevelops an oxygen requirement and/or increased work of breathing, HFNC will be recommenced at the original (maximal) flow rate. *No other form of respiratory support (eg. CPAP) will be used unless a decision to transfer the infant has been made, and NETS contacted for retrieval.
Sponsors
University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Hours to 24 Hours
Healthy volunteers
No
Inclusion criteria
Diagnosed with respiratory distress. Defined as at least one of the following: intercostal/subcostal recession, audible ‘grunt’, or tachypnoea (respiratory rate >60/min). 2. Who require any supplemental inspired oxygen to maintain peripheral oxygen saturation (Sp02) of 90-95% for a period of more than one hour. 3. Aged less than 24 hours.
Exclusion criteria
1. Gestational age at birth less than 32 completed weeks. The trial will continue to support and encourage the NHMRC recommendations for in utero transfer of infants expected to be born at less than 33weeks gestation. Furthermore, no change in practice will be made for those centres that routinely transfer in utero at gestational ages higher than 33 weeks. It is not uncommon, however, for babies of this gestation to be unavoidably born at a non-tertiary nursery. 2. Birth weight lower than that which the SCN would normally care for. 3. Apgar score less than or equal to 3 at 5 minutes of age (used as an arbitrary and de-facto indicator of possible perinatal asphyxia). 4. Any infant who is perceived by their paediatrician to need NICU care, or who has a known major congenital abnormality requiring care in a tertiary centre, or which may impact upon the infant’s condition after birth (eg. congenital cardiac disease, upper airway obstruction, gastrointestinal malformations).
Outcome results
None listed