Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000264583
Ethics application status
Approved
Date submitted
8/01/2003
Date registered
8/01/2003
Date last updated
7/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised controlled trial to see if Continuous Positive Airways Pressure will reduce the number of infants transferred from Special Care Nurseries to Intensive care Nurseries.
Scientific title
Randomised controlled trial of headbox oxygen versus Continuous Positive Airways Pressure (CPAP) to reduce up-transfer of infants with respiratory distress in non-teritary hospitals.
Secondary ID [1] 31 0
Perinatal Trials Registry: PTR401
Universal Trial Number (UTN)
Trial acronym
Bubbles for Babies
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Babies born with respiratory distress in non-tertiary centres. 32 0
Condition category
Condition code
Reproductive Health and Childbirth 37 37 0 0
Complications of newborn
Respiratory 38 38 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is CPAP at 5cms of water. Provided using Hudson Nasal prongs connected to an underwater seal.
Intervention code [1] 1092 0
Treatment: Devices
Comparator / control treatment
The control group receives standard of care treatment for respiratory distress.
Control group
Active

Outcomes
Primary outcome [1] 67 0
The primary outcome will be transfer or treatment failure, as determined by the following criteria:
1. HeadBoxOxygen (HBO) only. HBO will be considered to have failed if =60% oxygen is required to maintain a saturation of =94%, and if this requirement persists for more than one hour. (75% of the participating paediatricians would definitely transfer an infant requiring > 60% oxygen.).
2. CPAP only. CPAP will be considered to have failed if =50% oxygen is required to maintain a saturation of =94%, and if this requirement persists for more than one hour. As agreed with representatives of NICUs that use CPAP as frontline treatment, and in keeping with the principle that babies in CPAP who are in the same amount of oxygen as babies in a headbox are more unwell.
3. Both groups. The persistence of a CO2 level of > 60 on two successive gasses at least 1 hour apart. (75% of the participating paediatricians would definitely transfer an infant with a CO2 of > 60%).
4. Both groups. The persistence of a pH level of < 7.25 on two successive gasses at least 1 hour apart. (75% of the participating paediatricians would definitely transfer an infant with a pH level of < 7.25).
5. Both groups. Transfer may be arranged prior to meeting these criteria for any baby if so decided through consultation between the support hospital and the attending paediatrician. The justification for doing so will be clearly documented.
Timepoint [1] 67 0
Secondary outcome [1] 117 0
1. Length of time needing oxygen. The duration of respiratory support in air (i.e., without supplementary oxygen) will also be measured.
Timepoint [1] 117 0
Length of time in oxygen will be measured in hours. This will commence from the moment of treatment commencement post-randomisation. If oxygen is recommenced during the initial stay, or if an infant is up-transferred to a NICU, this time will be added.
Secondary outcome [2] 118 0
2. Length of stay. Length of stay to discharge home will be calculated for all babies. This will include up-transfers and any down-transfers until the infant is discharged home.
Timepoint [2] 118 0
Secondary outcome [3] 119 0
3. Parental stress. A questionnaire used to identify levels of stress.
Timepoint [3] 119 0
Secondary outcome [4] 120 0
4. Pneumothorax. All pneumothoraxes will be identified whether requiring a chest drain or not. The final diagnosis of a pneumothorax will be determined by radiologist.
Timepoint [4] 120 0
Secondary outcome [5] 121 0
5. Morbidity and mortality data will be collected on all babies. The following indicators will be used as a measure of morbidity: 1. Requirement of oxygen at 28 days of age. 2. Mortality 3. Intraventricular haemorrhage. Head ultra sound will be obtained on babies where clinically indicated by the paediatrician. Any other side effects, such as ulceration of the nares, will be recorded but not included as part of this outcome.
Timepoint [5] 121 0
Secondary outcome [6] 122 0
6. Nurse workload will be measured for all babies whether randomised to HBO or CPAP.
Timepoint [6] 122 0

Eligibility
Key inclusion criteria
1. dagnosed with respiratory distress. Defined as al least one of the following: recession, grunt, nasal flare, or tachypnoea (respiratory rate >60/minute)2. Who require >30% oxygen to maintain SaO2 or> or = 94% over a period of >30minutes.3. Babies aged less than 24 hours
Minimum age
Not stated
Maximum age
31 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Infants < 31wks gestation. 2. Infants <1200 grams. Corresponds to the 10th percentile for 31 weeks gestation. 3. Apgar score = 3 at 5minutes of age. Used as an arbitrary and de-facto indicator of possible perinatal asphyxia.4. Cardiac cause of respiratory distress. 5. Any infant who is perceived by their paediatrician to need NICU care. This “out clause” will provide an added safety mechanism and will cover infants with, for example, congenital anomalies. Potential implications for generalisability will be assessed by recording non-identifying details of all infants excluded for this reason, along with the reason for transfer.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation according to gestational age and centre of birth.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
21/08/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 54 0
Government body
Name [1] 54 0
National Health & Medical Research Council
Country [1] 54 0
Australia
Funding source category [2] 55 0
Charities/Societies/Foundations
Name [2] 55 0
Financial Markets Foundation
Country [2] 55 0
Australia
Primary sponsor type
Individual
Name
Adam Buckmaster
Address
Country
Secondary sponsor category [1] 40 0
University
Name [1] 40 0
University of Sydney
Address [1] 40 0
Country [1] 40 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 354 0
Central Coast Area Health Service
Ethics committee address [1] 354 0
Ethics committee country [1] 354 0
Australia
Date submitted for ethics approval [1] 354 0
Approval date [1] 354 0
Ethics approval number [1] 354 0
01/38
Ethics committee name [2] 355 0
Gold Coast Health Service
Ethics committee address [2] 355 0
Ethics committee country [2] 355 0
Australia
Date submitted for ethics approval [2] 355 0
Approval date [2] 355 0
Ethics approval number [2] 355 0
200306
Ethics committee name [3] 356 0
University of Sydney
Ethics committee address [3] 356 0
Ethics committee country [3] 356 0
Australia
Date submitted for ethics approval [3] 356 0
Approval date [3] 356 0
Ethics approval number [3] 356 0
6651
Ethics committee name [4] 357 0
Western Sydney Area health service HS/TG
Ethics committee address [4] 357 0
Ethics committee country [4] 357 0
Australia
Date submitted for ethics approval [4] 357 0
Approval date [4] 357 0
Ethics approval number [4] 357 0
2002/5/3.3 (1365)
Ethics committee name [5] 358 0
South western Sydney
Ethics committee address [5] 358 0
Ethics committee country [5] 358 0
Australia
Date submitted for ethics approval [5] 358 0
Approval date [5] 358 0
Ethics approval number [5] 358 0
AHS 04/034
Ethics committee name [6] 359 0
South Eastern Health service
Ethics committee address [6] 359 0
Ethics committee country [6] 359 0
Australia
Date submitted for ethics approval [6] 359 0
Approval date [6] 359 0
Ethics approval number [6] 359 0
01/133
Ethics committee name [7] 360 0
Illawarra Helath Service
Ethics committee address [7] 360 0
Ethics committee country [7] 360 0
Australia
Date submitted for ethics approval [7] 360 0
Approval date [7] 360 0
Ethics approval number [7] 360 0
HE02/024

Summary
Brief summary
Many babies are born with respiratory distress and require care in a Special Care Nursery (SCN). Whilts most of these babies get better with oxygen and other routine supports a number have to be transferred to a Neonatal Intensive Care Unit (NICU). Such a transfer has a major impact on the health of the baby and on the family unit and incurs a significant cost.
Continuous Positive Airways Pressure (CPAP) is used to treat infants with respiratory distress in Australian NICUs. This proposal seeks to compare, by randomised trial, nasal CPAP to head box oxygen in SCN, as means of early treatment of respiratory distress. The study is designed to be able to detect a 50% reduction in the number of babies meeting criteria that would ordinarily result in transfer to NICUs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35575 0
Address 35575 0
Country 35575 0
Phone 35575 0
Fax 35575 0
Email 35575 0
Contact person for public queries
Name 10281 0
Ms J. Foster
Address 10281 0
NSW Pregnancy and Newborn Services Network
University of Sydney
NSW 2006
Country 10281 0
Australia
Phone 10281 0
(02) 93518749
Fax 10281 0
Email 10281 0
jfoster@perinatal.usyd.edu.au
Contact person for scientific queries
Name 1209 0
Ms J. Foster
Address 1209 0
NSW Pregnancy and Newborn Services Network
University of Sydney, NSW
Country 1209 0
Australia
Phone 1209 0
(02) 93518749
Fax 1209 0
Email 1209 0
jfoster@perinatal.usyd.edu.au

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No Supporting Document Provided



Results publications and other study-related documents

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