Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000233921
Ethics application status
Approved
Date submitted
21/02/2011
Date registered
3/03/2011
Date last updated
9/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of headbox oxygen versus high flow nasal cannula (HFNC) for neonatal respiratory distress in non-tertiary hospitals
Scientific title
High-flow nasal cannulae versus ambient oxygen for the treatment of newborn infants with early respiratory distress in non-tertiary special care nurseries – A multicentre randomised controlled trial
Secondary ID [1] 259658 0
None
Universal Trial Number (UTN)
Trial acronym
High-flow for Infants in Non-Tertiary Centres (HINT Trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory distress 261222 0
Breathing support 261228 0
Condition category
Condition code
Respiratory 259370 259370 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 259373 259373 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 258085 0
Treatment: Devices
Comparator / control treatment
Ambient oxygen. Infants randomised to the control group (AO) will be managed as follows:
1. Infants will receive inspired oxygen into the crib/cot or via a 'head-box'. Inspired oxygen concentration will be adjusted in order to maintain Sp02 90-95%.
2. Receive standard supportive (intravenous fluids and dextrose, intragastric tube, and antibiotics as required) as decided by their paediatrician.
3. No other form of respiratory support (e.g. CPAP) will be permitted unless a decision to transfer the infant has been made and the Newborn Emergency Transport Service (NETS) have been contacted for retrieval.
4. Treatment will cease once the infant no longer requires oxygen therapy in order to maintain SpO2 90-95%.
Control group
Active

Outcomes
Primary outcome [1] 262186 0
Treatment failure or transfer to tertiary centre.
Treatment failure will be deemed to have occurred if any ONE of the following failure criteria is met:
1. Supplemental oxygen requirement >40% to maintain Sp02 90-95% for more than one hour.
2. A carbon dioxide (CO2) level >60mmHg, persisting on two successive blood gases taken at least one hour apart.
3. A pH level <7.25, persisting on two successive gases at least one hour apart.
Timepoint [1] 262186 0
32 completed weeks post menstrual age
Secondary outcome [1] 273285 0
Length of time receiving supplemental oxygen
Timepoint [1] 273285 0
to hospital discharge
Secondary outcome [2] 273286 0
Total length of hospital admission
Timepoint [2] 273286 0
to hospital discharge
Secondary outcome [3] 273287 0
Incidence of pneumothorax (diagnosed on chest x-ray)
Timepoint [3] 273287 0
to hospital discharge
Secondary outcome [4] 273288 0
Parental satisfaction score using a likert scale.
Timepoint [4] 273288 0
to hospital discharge

Eligibility
Key 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.
Minimum age
1 Hours
Maximum age
24 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All newborn infants who are brought to the SCN with signs of respiratory distress will have their SpO2 measured. If required, supplemental oxygen will be commenced/continued and titrated with the aim to ensure the SpO2 is kept between 90-95%, inclusive.
Oxygen will be delivered into the cot/crib or via a head-box. Consent will be sought for those infants who require any oxygen on the understanding that the infant will only be randomised if they continue to require supplemental oxygen for one hour. Central randomisation by computer will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computer generated. Randomisation will be blocked by gestational age-group (less than 37 weeks completed gestation at birth; greater than or equal to 37 weeks completed gestation at birth), and centre.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
520
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258548 0
Other Collaborative groups
Name [1] 258548 0
Hunter Medical Research institute
Country [1] 258548 0
Australia
Funding source category [2] 287579 0
University
Name [2] 287579 0
University of Newcastle
Country [2] 287579 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Newcastle NSW 2300
Country
Australia
Secondary sponsor category [1] 257682 0
None
Name [1] 257682 0
Address [1] 257682 0
Country [1] 257682 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260516 0
Maitland Hospital
Ethics committee address [1] 260516 0
Ethics committee country [1] 260516 0
Australia
Date submitted for ethics approval [1] 260516 0
30/03/2011
Approval date [1] 260516 0
Ethics approval number [1] 260516 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32252 0
A/Prof Adam Buckmaster
Address 32252 0
Gosford District Hospital
Holden St
Gosford, NSW 2250
Country 32252 0
Australia
Phone 32252 0
+61 2 43202111
Fax 32252 0
Email 32252 0
[email protected]
Contact person for public queries
Name 15499 0
A/Prof Associate Professor Adam Buckmaster
Address 15499 0
Gosford Hospital
Gosford NSW Cnr Holden Street and Racecourse Road
GOSFORD NSW 2250
PO BOX 361, GOSFORD NSW 2250
Country 15499 0
Australia
Phone 15499 0
+61 (0)412 119 294
Fax 15499 0
Email 15499 0
[email protected]
Contact person for scientific queries
Name 6427 0
A/Prof Associate Professor Adam Buckmaster
Address 6427 0
Gosford Hospital
Gosford NSW Cnr Holden Street and Racecourse Road
GOSFORD NSW 2250
PO BOX 361, GOSFORD NSW 2250
Country 6427 0
Australia
Phone 6427 0
+61 (0)412 119 294
Fax 6427 0
Email 6427 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHigh flow nasal cannula for respiratory support in term infants.2023https://dx.doi.org/10.1002/14651858.CD011010.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.