Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000677000
Ethics application status
Not yet submitted
Date submitted
11/08/2010
Date registered
18/08/2010
Date last updated
18/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
High Flow support versus Continuous Positive Airway Pressure (CPAP) support in non-acute
respiratory support for preterm infants from 30 weeks corrected gestation
Scientific title
In preterm infants from 30 weeks corrected gestation, how does High Flow respiratory Support compared with Continuous Positive Airway Pressure (CPAP) respiratory Support affect the infant's short term respiratory outcomes?
Secondary ID [1] 252427 0
n/a
Universal Trial Number (UTN)
U1111-1116-4642
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
respiratory failure in preterm infants from 30 weeks corrected gestation 257935 0
Condition category
Condition code
Respiratory 258106 258106 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 258116 258116 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
high flow gas support
(minimum 4 litres/min - maximum 6 litres/min in 25% oxygen)

Dose size determined by level of support needed (ie. all will start on 6 litres/min, then be reduced as needed)

It will be administered continuously via nasal cannula for a maximum of 4 weeks (can be weaned off earlier if no support is necessary).
Intervention code [1] 256993 0
Treatment: Devices
Comparator / control treatment
CPAP (no minimum - maximum 5 cm H20 pressure in <= 25% oxygen)

Dose size determined by level of support needed (ie. all will start on 5 cm H20 pressure, then be reduced as needed).

It will be administered continuously via nasal cannula for a maximum of 4 weeks (can be weaned off earlier if no support is necessary).
Control group
Active

Outcomes
Primary outcome [1] 258966 0
Failure of High Flow - will be determined if the baby was placed on CPAP or higher level of respiratory support.
Timepoint [1] 258966 0
during the 4 week study period
Primary outcome [2] 258967 0
Stability on treatment- number of bradycardia/apnoea episodes per day

Determined by the need for tactile stimulation by staff in order to revert the bradycardic episode back to normal.
Timepoint [2] 258967 0
daily collection during 4 week study period
Primary outcome [3] 258968 0
Chronic lung disease (CLD) at 36 weeks will be determined as the need for oxygen or respiratory support at the corrected gestation of 36 weeks.
Timepoint [3] 258968 0
at 2 weeks after intervention cessation; at 36 weeks corrected gestational age of enrolled infant
Secondary outcome [1] 265150 0
Nasal damage assessed by clinical observation
Timepoint [1] 265150 0
daily collection during 4 week study period
Secondary outcome [2] 265151 0
Time to full feeds- reached when the infant is receiving 120 ml/kg/day of milk.
Timepoint [2] 265151 0
during the infant's stay in the Neonatal Intensive Care Unit (NICU)
Secondary outcome [3] 265152 0
Growth- weight, head circumference, length. Assessed using PEAPOD.
Timepoint [3] 265152 0
twice weekly during infant's stay in NICU
Secondary outcome [4] 265153 0
Clinical abdominal distension assessed by clinical observation
Timepoint [4] 265153 0
daily collection during 4 week study period
Secondary outcome [5] 265154 0
Number of kangaroo holds during treatment assessed from patient bedside notes
Timepoint [5] 265154 0
daily collection during 4 week study period

Eligibility
Key inclusion criteria
Infants are eligible to enrol if-
1. They are at least 5 days old
2. They are at least 30 weeks corrected gestation
3. They are less than 32 weeks corrected gestation
4. They are CPAP dependent but not requiring greater than 5cm H2O preessure or greater than 25% oxygen
5. Parental consent is obtained
Minimum age
5 Days
Maximum age
60 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants are ineligible to enroll if-
1. There is a major congenital malformation present
2. They are suffering severe asphyxia
3. Clinical airway obstruction is present
4. Parental consent is not obtained
5. Receiving more than CPAP/5 in 25% inclusion

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)
Prior to randomisation, researchers will ensure infants are eligible by making sure they are a minimum of 30 weeks corrected gestation, a minimum of 5 days old and obtain parental consent.

After that, dependence to CPAP needs to be determined. If an eligible infant fails the trial-off CPAP, they need to be immediately randomised via the computer system by either a study researcher or attending staff member:
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation by gestational age and gender. Then randomisation by using a randomisation table created by a computer software.
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
31/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257444 0
Self funded/Unfunded
Name [1] 257444 0
n/a
Country [1] 257444 0
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Liverpool Health Service
Locked Mailbag 7103
Liverpool NSW 1871
Country
Australia
Secondary sponsor category [1] 256675 0
None
Name [1] 256675 0
n/a
Address [1] 256675 0
n/a
Country [1] 256675 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259473 0
Human Research and Ethics Commitee (South West Sydney)
Ethics committee address [1] 259473 0
Ethics committee country [1] 259473 0
Australia
Date submitted for ethics approval [1] 259473 0
31/05/2010
Approval date [1] 259473 0
Ethics approval number [1] 259473 0
2010/067

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31509 0
Address 31509 0
Country 31509 0
Phone 31509 0
Fax 31509 0
Email 31509 0
Contact person for public queries
Name 14756 0
Ashley McEwan
Address 14756 0
Department of Newborn Care
Liverpool Health Service
Locked Mailbag 7103
LIVERPOOL BC NSW 1871
Country 14756 0
Australia
Phone 14756 0
+61 0425231378
Fax 14756 0
+61 2 9828 5572
Email 14756 0
[email protected]
Contact person for scientific queries
Name 5684 0
Dr. Ian Callander
Address 5684 0
Department of Newborn Care
Liverpool Health Service
Locked Mailbag 7103
LIVERPOOL BC NSW 1871
Country 5684 0
Australia
Phone 5684 0
+61 0418 638758
Fax 5684 0
+61 2 9828 5572
Email 5684 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 preterm infants.2016https://dx.doi.org/10.1002/14651858.CD006405.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.