Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001003066
Ethics application status
Approved
Date submitted
23/08/2010
Date registered
17/11/2010
Date last updated
22/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Heated Humidified High Flow Nasal Cannula for Weaning from Nasal Continuous Positive Airway Pressure Trial in Preterm Infants (The HiFloW Trial)
Scientific title
The HiFloW Trial: A randomised controlled trial to evaluate the effectiveness of heated, humidified high flow nasal cannula (HHHFNC) in the withdrawal of nasal continuous positive airway pressure (nCPAP) in preterm infants
Secondary ID [1] 252546 0
None
Universal Trial Number (UTN)
Trial acronym
HiFloW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic lung disease 258025 0
Breathing support 258026 0
Premature infant care 258027 0
Condition category
Condition code
Respiratory 258193 258193 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 258791 258791 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2x2 factorial design:
Group 1:Abrupt weaning from nCPAP to HHHFNC - infant is taken OFF nCPAP and put onto HHHFNC with initial flow rate titrated to deliver pressure initially produced on nCPAP, then gradually decreasing flow rate at increments of 1litre per min at the discretion of medical team. Infant will remain on this intervention until failure criteria met or is withdrawn. Infants who meet failure criteria will be put back onto nCPAP for at least 48hours until they meet stability criteria before returning to the same arm of the trial.

Group 2: Abrupt weaning from nCPAP without HHHFNC - infant is taken OFF nCPAP and put into crib air/oxygen (<25%) or low flow nasal cannula oxygen if required (<1L/min). Infant will remain on this intervention until failure criteria met or is withdrawn. Infants who meet failure criteria will be put back onto nCPAP for at least 48hours until they meet stability criteria before returning to the same arm of the trial.

Group 3: Gradual weaning from nCPAP to HHHFNC – infant alternates between time ON and OFF nCPAP. HHHFNC is given during OFF periods with flow rate titrated to deliver pressure initially produced on nCPAP, gradually increasing HHHFNC time by 1h increments and/or according to infant stability until nCPAP can be stopped completely.

Group 4: Gradual weaning from nCPAP without HHHFNC – infant alternates between time ON and OFF nCPAP by alternating between time on and off CPAP as the infant tolerates, gradually increasing time OFF until nCPAP can be stopped completely.
Intervention code [1] 257068 0
Treatment: Devices
Comparator / control treatment
Each of the four groups will be compared in a 2x2 factorial design
Control group
Active

Outcomes
Primary outcome [1] 259050 0
Chronic lung disease, defined as requiring oxygen or respiratory support at 36 weeks Postmenstrual Age
Timepoint [1] 259050 0
36 weeks postmenstrual age
Primary outcome [2] 259051 0
Length of Hospital Stay (days), defined as time of randomisation to time of hospital discharge. This will be obtained via data linkage to patient medical records.
Timepoint [2] 259051 0
Discharge from hospital
Secondary outcome [1] 265313 0
Respiratory morbidity, from data linkage to patient medical records
Timepoint [1] 265313 0
Asssessed continuously from randomisation until discharge from the Neonatal Intensive Care Unit (NICU)
Secondary outcome [2] 265314 0
Infant feeding and growth, from reviewing nursing bedside charts and medical records
Timepoint [2] 265314 0
36 weeks PMA
Secondary outcome [3] 265315 0
Infant morbidity including necrotising enterocolitis, patent ductus arteriosus, retinopathy of prematurity and late onset sepsis. This will be obtained by reviewing medical records.
Timepoint [3] 265315 0
Asssessed continuously from randomisation until discharge from NICU
Secondary outcome [4] 265316 0
Mother-infant interaction, based on nursing record of the duration of mother-infant cuddling from randomisation to discharge from NICU
Timepoint [4] 265316 0
34 weeks PMA
Secondary outcome [5] 265317 0
Nursing workload / intensity measured using a modified nursing workload intensity survey
Timepoint [5] 265317 0
Nursing staff will fill survey at the end of each shift

Eligibility
Key inclusion criteria
All babies born less than 30 completed weeks gestational age, AND
1. Clinically stable on less than or equal to 5cm H2O nasal continuous positive airway pressure (nCPAP) with mouth closed OR
2. Clinically stable on nCPAP (any level) but tolerating 6 hours with mouth open, OR
3. Clinically stable on nCPAP (any level) and tolerating 6 hours OFF nCPAP
Minimum age
24 Weeks
Maximum age
30 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infection defined as positive blood or cerebrospinal fluid culture within the previous 48 hours
Major congenital or chromosomal abnormalities
Severe neurologic insults or neuromuscular disease

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)
Infants will be enrolled after informed parental consent is obtained and eligibility confirmed by completing an enrolment sheet. Once the infant meets a set of stability criteria, he/she will be randomised into one of four arms via use of sequentially numbered opaque sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of randomisation will be randomly allocated by use of a random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2010
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
30/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 257514 0
Hospital
Name [1] 257514 0
Royal Prince Alfred (RPA) Newborn Care Research Fund
Country [1] 257514 0
Australia
Primary sponsor type
Hospital
Name
RPA Hospital
Address
Missenden Rd
Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 256747 0
None
Name [1] 256747 0
Address [1] 256747 0
Country [1] 256747 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259541 0
Ethics Review Committee (Royal Prince Alfred Hospital Zone) of the Sydney South West Area Health Service
Ethics committee address [1] 259541 0
Ethics committee country [1] 259541 0
Australia
Date submitted for ethics approval [1] 259541 0
Approval date [1] 259541 0
15/10/2010
Ethics approval number [1] 259541 0

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

Contacts
Principal investigator
Name 31557 0
A/Prof David Osborn
Address 31557 0
RPA Newborn Care, Royal Prince Alfred Hospital, Camperdown, NSW, Australia 2050
Country 31557 0
Australia
Phone 31557 0
61295158363
Fax 31557 0
Email 31557 0
[email protected]
Contact person for public queries
Name 14804 0
David Osborn
Address 14804 0
RPA Newborn Care
RPA Hospital
Missenden Rd
Camperdown NSW 2050
Country 14804 0
Australia
Phone 14804 0
61295158363
Fax 14804 0
Email 14804 0
[email protected]
Contact person for scientific queries
Name 5732 0
David Osborn
Address 5732 0
RPA Newborn Care
RPA Hospital
Missenden Rd
Camperdown NSW 2050
Country 5732 0
Australia
Phone 5732 0
61295158363
Fax 5732 0
Email 5732 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
Dimensions AIRandomised controlled trial of weaning strategies for preterm infants on nasal continuous positive airway pressure2015https://doi.org/10.1186/s12887-015-0462-0
N.B. These documents automatically identified may not have been verified by the study sponsor.