Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000375550
Ethics application status
Approved
Date submitted
5/02/2001
Date registered
5/02/2001
Date last updated
23/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Benefits of Oxygen Saturation Targeting (BOOST) trial: different oxygen levels for preterm infants
Scientific title
A randomised trial of standard versus higher oxygen saturation levels on long term growth and development of infants
Secondary ID [1] 22 0
Perinatal Trials Registry: PTR346
Universal Trial Number (UTN)
Trial acronym
BOOST Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preterm infants 22 0
Condition category
Condition code
Reproductive Health and Childbirth 22 22 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Targeting two different oxygen saturation target ranges, SpO2 (oxygen saturation) 91-94% (control) vs SpO2 95-98% (treatment), using pulse oximetry from 32 weeks postmentrual age for the duration of the infant's supplental oxygen need.
Intervention code [1] 1088 0
Treatment: Other
Comparator / control treatment
SpO2 (oxygen saturation) 91-94%
Control group
Active

Outcomes
Primary outcome [1] 43 0
Mean weight, length and head cicumference
Timepoint [1] 43 0
38 weeks postmenstrual age
Primary outcome [2] 44 0
mean proportion of babies less than the 10th percentile for weight, length, and head circumference
Timepoint [2] 44 0
one year corrected age
Primary outcome [3] 45 0
Presence of a major developmental abnormality (blindness; cerebral palsy; or a Griffith score <2 standard deviations below the mean)
Timepoint [3] 45 0
one year corrected age
Secondary outcome [1] 64 0
1. Assessment of maternal depression.
Timepoint [1] 64 0
At entry into the study at 32 weeks postmenstrual age (pma).
Secondary outcome [2] 65 0
Assessment of child temperament.
Timepoint [2] 65 0
At 4 , 12 months
Secondary outcome [3] 66 0
Parental stress
Timepoint [3] 66 0
At 4, 12 months
Secondary outcome [4] 67 0
Maternal depression during follow-up.
Timepoint [4] 67 0
At trial entry, 4, 12 months
Secondary outcome [5] 68 0
2. Health service use during first year of life.
Timepoint [5] 68 0
Parental self report at 4, 12 months.
Secondary outcome [6] 69 0
3. Presence and progrssion of retinopathy of prematurity (ROP).
Timepoint [6] 69 0
Assessed from 32 weeks pma at 2 weekly intervals until ROP resolved.
Secondary outcome [7] 70 0
4. Sudden unexplained deaths and other mortality in the first year of life.
Timepoint [7] 70 0
Recorded if/when events occurred).

Eligibility
Key inclusion criteria
i) babies born at less than 30 weeks gestational age who remain oxygen-dependent at 32 weeks postmenopausal age (gestational age plus postnatal age).ii) Agreement of parents to participate in long-term follow-up.iii) registration at one of the level three neonatal intensive care units (NICU) of the eight participating preinatal centres. These are: Canberra Hospital, Woden Valey (ACT); John Hunter Hospital, Newcastle (NSW); King George V Hospital, Camperdown (NSW); Liverpool Hospital, Liverpool (NSW); Mater Mothers Hospital, Brisbane (QLD); Nepean Hospital, Penrith (NSW); Royal Hospital for Women, Ranwick (NSW); and Royal North Shore Hospital, St Leonards (NSW)
Minimum age
24 Weeks
Maximum age
29 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) lethal and selected congential defects, including congential heart defects; congential lung defects; intestinal atresias or stenoses; anomalies of the abdominal wallii) major surgery and disease complications influencing growth and development directly, including: intestinal resections/ostomies/fistuals; ventriculostomies; ventricular shuntsiii) grade 3 or grade 4 intraventricular haemorrhage (IVH) at 32 weeks postmenstrual age diagnosed by head ultrasound at enrolment or earlieriv) periventricular (cystic) leukomalacia (PVL) at 32 weeks postmenopausal age diagnosed by head ultrasound at enorlment or earlierv) porencephalic cyst at 32 weeks postmenstrual age diagnosed by head ultrasound at enrolment or earliervi) other established neurological injury or abnormailty at 32 weeks postmenstrual age diagnosed by head ultrasound at enrolment or earliervii) babies expected to die imminetly at the time of eligibility assessment as determined by the primary clinicianviii) babies not exptected to live with the biological mother (if adoption is planned or if baby is to live with family other than the biological mother, as noted in medical record or after discussion with clinical staff)ix) infants of multiple confinements if more than tow infants are eligible at 32

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)
central telephone randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random number sequence, with dynamic balancing, stratified for enrolment centre, multiple/singleton birth and gestational age category
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Double blinding of treatment allocation was achieved using the following method: the allocated study oximeter was adjusted to display a reading either 2% above of below the infant's actual saturation value. All infants in the trial were asked to target the blinded range of 93-96% which meant that some babies were actually targeting a range of 91-94% whilst others were actually targeting a range of 95-98%.
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/1996
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
358
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 30 0
Government body
Name [1] 30 0
National Health & Medical Research Council project grant
Country [1] 30 0
Australia
Funding source category [2] 31 0
Government body
Name [2] 31 0
NHMRC Postgraduate Scholarship
Country [2] 31 0
Australia
Funding source category [3] 32 0
Charities/Societies/Foundations
Name [3] 32 0
Financial Markets Foundation for Children
Country [3] 32 0
Australia
Primary sponsor type
University
Name
Centre for Perinatal Health Services Research, University of Sydney
Address
Sydney
Country
Australia
Secondary sponsor category [1] 29 0
None
Name [1] 29 0
Nil
Address [1] 29 0
Country [1] 29 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 274 0
University of Sydney
Ethics committee address [1] 274 0
Ethics committee country [1] 274 0
Australia
Date submitted for ethics approval [1] 274 0
Approval date [1] 274 0
17/06/1995
Ethics approval number [1] 274 0
Ethics committee name [2] 275 0
Central Sydney Area Health Service
Ethics committee address [2] 275 0
Ethics committee country [2] 275 0
Australia
Date submitted for ethics approval [2] 275 0
Approval date [2] 275 0
Ethics approval number [2] 275 0
95-0055,
Ethics committee name [3] 276 0
Central Sydney Area Health Service
Ethics committee address [3] 276 0
Ethics committee country [3] 276 0
Australia
Date submitted for ethics approval [3] 276 0
Approval date [3] 276 0
Ethics approval number [3] 276 0
X99-105
Ethics committee name [4] 277 0
South Western Sydney Area Health Service
Ethics committee address [4] 277 0
Ethics committee country [4] 277 0
Australia
Date submitted for ethics approval [4] 277 0
Approval date [4] 277 0
18/06/1905
Ethics approval number [4] 277 0
96/05
Ethics committee name [5] 278 0
Northern Sydney Area Health Service
Ethics committee address [5] 278 0
Ethics committee country [5] 278 0
Australia
Date submitted for ethics approval [5] 278 0
Approval date [5] 278 0
17/06/1905
Ethics approval number [5] 278 0
9511-164M
Ethics committee name [6] 279 0
Hunter Area Health Service
Ethics committee address [6] 279 0
Ethics committee country [6] 279 0
Australia
Date submitted for ethics approval [6] 279 0
Approval date [6] 279 0
17/06/1905
Ethics approval number [6] 279 0
Ethics committee name [7] 280 0
University of Wollongong
Ethics committee address [7] 280 0
Ethics committee country [7] 280 0
Australia
Date submitted for ethics approval [7] 280 0
Approval date [7] 280 0
19/06/1905
Ethics approval number [7] 280 0
HE97/051
Ethics committee name [8] 281 0
Woden Valley Hospital Ethics Committee
Ethics committee address [8] 281 0
Ethics committee country [8] 281 0
Australia
Date submitted for ethics approval [8] 281 0
Approval date [8] 281 0
18/06/1905
Ethics approval number [8] 281 0
ETH.3/96.54
Ethics committee name [9] 282 0
South Eastern Sydney Area Health Service
Ethics committee address [9] 282 0
Ethics committee country [9] 282 0
Australia
Date submitted for ethics approval [9] 282 0
Approval date [9] 282 0
17/06/1905
Ethics approval number [9] 282 0
95/189
Ethics committee name [10] 283 0
Western Sydney Area Health Service
Ethics committee address [10] 283 0
Ethics committee country [10] 283 0
Australia
Date submitted for ethics approval [10] 283 0
Approval date [10] 283 0
18/06/1905
Ethics approval number [10] 283 0
96/003
Ethics committee name [11] 284 0
Mater Misericordiae Hospital Brisbane
Ethics committee address [11] 284 0
Ethics committee country [11] 284 0
Australia
Date submitted for ethics approval [11] 284 0
Approval date [11] 284 0
20/06/1905
Ethics approval number [11] 284 0
084M

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

Contacts
Principal investigator
Name 35555 0
Address 35555 0
Country 35555 0
Phone 35555 0
Fax 35555 0
Email 35555 0
Contact person for public queries
Name 10277 0
Lisa Askie
Address 10277 0
NHMRC Clinical Trial Centre
University of Sydney
88 Mallett Street
Camperdown NSW 2050
Country 10277 0
Australia
Phone 10277 0
+61 2 9562 5000
Fax 10277 0
+61 2 9565 1863
Email 10277 0
[email protected]
Contact person for scientific queries
Name 1205 0
Lisa Askie
Address 1205 0
NHMRC Clinical Trial Centre
University of Sydney
88 Mallett Street
Camperdown. NSW. 2050
Country 1205 0
Australia
Phone 1205 0
+61 2 9562 5000
Fax 1205 0
+61 2 9565 1863
Email 1205 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
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