High-flow nasal cannulae use in non-tertiary centres for early respiratory distress in newborn infants: The HUNTER trial.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001203640
• Date of registration: 17/11/2014
• Prospective Registration: Yes
• Primary sponsor: Newborn Research Centre, The Royal Women's Hospital
• Public title: High-flow nasal cannulae use in non-tertiary centres for early respiratory distress in newborn infants: The HUNTER trial.
• Scientific title: A comparison of treatment failure rates between newborn infants randomised to either high-flow nasal cannulae or continuous positive airway pressure as primary respiratory support in Australian non-tertiary special care nurseries.
• Date of first enrolment: 13/04/2015
• Target sample size: 750
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614001203640.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Brett Manley

• Name: Dr Brett Manley

Key inclusion & exclusion criteria

Inclusion criteria: 1. Gestational age 31 weeks' or above by best obstetric estimate
2. Birth weight >1200 grams
3. Age <24 hours
4. Admitted to the special care nursery of a participating centre
5. Require non-invasive breathing support after admission to the special care nursery, or require supplemental oxygen to maintain peripheral oxygen saturation 91-95% for >1 hour
Exclusion criteria: 1. After admission to the SCN, the infants has already received >4 hours of CPAP
2. Previous endotracheal intubation and positive pressure ventilation, or imediate need for endotracheal intubation as determined by the treating paediatrician
3. Known major congenital abnormality which may impact upon the infant's condition after birth (eg. complex congenital cardiac disease, upper airway obstruction, gastrointestinal malformations)
4. Any infant who is judged by their paediatrician to require transfer to a tertiary hospital for ongoing care

Age minimum: Hours
Age maximum: 24 Hours
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Respiratory distress syndrome (RDS) ;Transient tachypnoea of the newborn (TTN);
Respiratory distress syndrome (RDS)

Transient tachypnoea of the newborn (TTN)

Reproductive Health and Childbirth - Complications of newborn

Respiratory - Other respiratory disorders / diseases

Intervention(s)

High-flow nasal cannulae (HFNC) - heated, humidifed gas (blended air/oxygen) delivered at gas flows between 6-8 Litres per minute via the Fisher & Paykel 'Optiflow Junior' circuit and prongs. HFNC will be weaned/ceased when the infant has no supplemental oxygen requirement, or has required <25% supplemental oxygen for >24 hours.

Primary Outcome(s)

Treatment failure within 72 hours of randomisation. Treatment failure has occurred if any of the following conditions are satisfied within 72 hours of an infant being randomised:
1. The infant is receiving maximal therapy (CPAP 8 cm H2O or HFNC 8 L/min) and has a fraction of inspired oxygen (FiO2) greater than or equal to 0.40 for more than 1 hour to maintain peripheral oxygen saturation (SpO2) 91-95%
2. The infant is receiving maximal therapy (CPAP 8 cm H2O or HFNC 8 L/min) and has both a pH <7.20 and pCO2 >60 mm Hg on two blood gas samples (which can be capillary, venous or arterial). The first sample should be collected at least 1 hour after initiation of the assigned treatment, and the second taken at least 1 hour after the first.
3. The infant is receiving maximal therapy (CPAP 8 cm H2O or HFNC 8 L/min) and has >1 apnoea receiving positive pressure ventilation within any 24-hour period, or >6 apnoeas in any 6 hour period receiving intervention (stimulation or increased oxygen)
4. The treating paediatrician determines that urgent intubation and mechanical ventilation is required
5. The treating paediatrician determines that the infant requires transfer to a tertiary centre through consultation with the local newborn emergency transport service (NETS NSW or PIPER Victoria).
[72 hours after randomisation]

Secondary Outcome(s)

Number of days to reach full suck feeds, defined as tolerating suck feeds without any requirement for intravenous fluids or naso/orogastric feeds for >24 hours [Discharge home from hospital]

Nursing workload, measured using a validated tool (PAONCIL score)[The nurse caring for the infant for the most time during each nursing shift will complete the survey at the end of the shift. Surveys will completed after each nursing shift whilst the infant remains on respiratory support with either HFNC or CPAP during the primary outcome period (72 hours after randomisation).


]

Parental satisfaction, measured using a validated questionnaire (Parental stress scale [PSS]-NICU)[Completed on the day of discharge home by the parent that was most in attendance in the nursery during their infant's admission, .
]

Requirement for supplemental oxygen at 28 days of age, and at 36 weeks' corrected gestational age for infants born <32 weeks' gestation.[28 days of age, and 36 weeks' corrected gestational age for infants born <32 weeks' gestation]

Length of time (hours) requiring supplemental oxygen[Discharge home from hospital]

Total length of hospital admission (days), and length of admission to a tertiary centre (days) [Discharge home from hospital]

Air leak from the lung (pneumothorax) requiring drainage via needle thoraccentesis or intercostal catheter insertion[Discharge home from hospital]

Weight gain (grams) from birth to hospital discharge[Discharge home from hospital]

Duration of any respiratory support (hours), including HFNC, CPAP, and mechanical ventilation, and duration of each type of respiratory support (hours) [Discharge home from hospital]

Cost-benefit analysis: A health economist will estimate differences between the interventions based on the costs of equipment, care in SCNs and NICUs, costs to the family, and the costs of transfer (both infant and maternal) [Discharge home from hospital]

Mechanical ventilation via an endotracheal tube in the first 72 hours after randomisation, and at any time before discharge home from hospital[72 hours after randomisation, and before discharge home from hospital]

Mortality[Discharge home from hospital]

Proportion of infants fully breastfed at discharge
[Discharge home from hospital]

Nasal trauma, as recorded on a nasal trauma scoring chart during treatment with the assigned intervention[Discharge home from hospital]

Number of days receiving any intravenous fluids[Discharge home from hospital]

Secondary ID(s)

Nil

Source(s) of Monetary Support

National Health and Medical Research Council (NHMRC), Australia

Newborn Research Centre, The Royal Women's Hospital

Ethics review

Status: Approved
Approval date:
Contact:

Royal Children's Hospital Human Research Ethics Committee