ANZCTR - Registration

Registration number

ACTRN12605000055606

Ethics application status

Approved

Date submitted

14/07/2005

Date registered

1/08/2005

Date last updated

8/06/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

BOOST II: Benefits Of Oxygen Saturation Targeting Study

Scientific title

Which oxygen saturation level should we use for very premature infants? A randomised controlled trial to investigate the effect of two slightly different oxygen levels on the health of very premature infants

Secondary ID [1]

Oxygen trial

Secondary ID [2]

Oxygen trial

Universal Trial Number (UTN)

Trial acronym

BOOST II

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Preterm infants

Condition category

Condition code

Reproductive Health and Childbirth

Normal pregnancy

Reproductive Health and Childbirth

Childbirth and postnatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Lower Oxygen Saturation (85%-89%) versus Higher Oxygen Saturation (91%-95%)

Intervention code [1]

None

Comparator / control treatment

This is a comparison study and aims to compare the two ranges within the normal clinical practice of 85-95% oxygen saturations. At the moment neither the Lower (85-89%) nor the Higher Oxygen Saturations (91-95%) is seen as the standard, and the purpose of the study is to compare both against each other in order to determine the ideal target within that range.

Control group

Dose comparison

Outcomes

Primary outcome [1]

Prior to unblinding the data for analysis, a Statistical Analysis Plan was produced and signed off by Prof Tarnow-Mordi, Dr Adrienne Kirby and Prof Val Gebski on 10th February, 2014.

A specific process for determining the primary outcome of death or disability was included, as follows (Section 5.5.)

Infants will be classified as having had the primary endpoint if (a) they have died prior to 2 years corrected gestational age; or (b) assessment at 2 years corrected gestational age shows major disability.

If an infant’s survival status at 2 years is unknown, or they are known to be alive but information on major disability is not available, their primary outcome will be missing.

The classification of infants as having a major disability is determined from:
* Bayley III Developmental Assessment completed by a blinded psychologist; or in some cases Bayley II Developmental Assessment
* Health Status assessment completed by a blinded paediatrician; or in some cases a Short Health Status Questionnaire collected mainly via phone call to parents or a GP visit if this is not available

An infant will be classified as having major disability if they are alive at 2 years corrected gestational age and meet at least one of the following criteria:
* Cerebral palsy with GMFCS level >= 2, as indicated on the health status (Q29) or short health status (Q1) assessments
* Legal blindness, as indicated on the on the health status (Q7) or short health status (Q2) assessments
* Hearing loss requiring hearing aids, as indicated on the health status (Q11) or short health status (Q3) assessments
* Composite cognitive score < 85 or composite language score < 85 on the Bayley III assessment; or cognition Mental Development Index (MDI) < 70 on the Bayley II assessment

If cognitive disability cannot be determined because the relevant Bayley III or Bayley II items are missing, the final criterion above can be replaced by any one of the following from the health status assessment:
* Uses less than 10 words (Q13); or language problems indicated on the short health assessment (Q4)
* Delayed development by more than 12 months (Q32)
* Other severe impairment (Q34)

If the infant does not meet any of the first three criteria, and all information on the Bayley assessment and these substitute criteria is also missing, the infant’s primary endpoint status will be missing.

Timepoint [1]

At 2 years old corrected for gestation at birth.

Secondary outcome [1]

ROP of prematurity

Timepoint [1]

At 2 years old corrected for gestation at birth.

Secondary outcome [2]

Duration of oxygen therapy

Timepoint [2]

At 2 years old corrected for gestation at birth.

Secondary outcome [3]

Duration of respiratory support

Timepoint [3]

At 2 years old corrected for gestation at birth.

Secondary outcome [4]

PDA

Timepoint [4]

At 2 years old corrected for gestation at birth.

Secondary outcome [5]

NEC

Timepoint [5]

At 2 years old corrected for gestation at birth.

Secondary outcome [6]

Chronic lung disease

Timepoint [6]

Treated with oxygen at 36 weeks gestational age.

Secondary outcome [7]

Growth

Timepoint [7]

At 2 years old corrected for gestation at birth.

Secondary outcome [8]

Re-admissions to hospital

Timepoint [8]

Up to 2 years old

Secondary outcome [9]

Cerebral palsy and unable to walk

Timepoint [9]

At 2 years corrected gestational age.

Secondary outcome [10]

Blindness (<6/60 vision)

Timepoint [10]

At 2 years old corrected for gestation at birth.

Secondary outcome [11]

Deaf using hearing aid

Timepoint [11]

At 2 years old corrected for gestation at birth.

Secondary outcome [12]

Mean MDI and PDI scores on Bayley Scales

Timepoint [12]

At 2 years old corrected for gestation at birth.

Secondary outcome [13]

Death

Timepoint [13]

After 4 weeks primarily attributable to pulmonary causes.

Eligibility

Key inclusion criteria

a) born <28 weeks gestation b) less than 24 hours of agec) there is informed consent by parent(s) or legal guardian

Minimum age

0 Days

Maximum age

1 Days

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

a) There is a known congenital anomaly that could affect oxygenation or developmentb) attendance for follow-up for 2 years is judged unlikely.

Study design

Statistical methods / analysis

Prior to unblinding the data for analysis, a Statistical Analysis Plan was produced and signed off by Prof Tarnow-Mordi, Dr Adrienne Kirby and Prof Val Gebski on 10th February, 2014.

A specific process for determining the primary outcome of death or disability was included, as follows (Section 5.5.)

Infants will be classified as having had the primary endpoint if (a) they have died prior to 2 years corrected gestational age; or (b) assessment at 2 years corrected gestational age shows major disability.

If an infant’s survival status at 2 years is unknown, or they are known to be alive but information on major disability is not available, their primary outcome will be missing.

The classification of infants as having a major disability is determined from:
* Bayley III Developmental Assessment completed by a blinded psychologist; or in some cases Bayley II Developmental Assessment
* Health Status assessment completed by a blinded paediatrician; or in some cases a Short Health Status Questionnaire collected mainly via phone call to parents or a GP visit if this is not available

An infant will be classified as having major disability if they are alive at 2 years corrected gestational age and meet at least one of the following criteria:
* Cerebral palsy with GMFCS level >= 2, as indicated on the health status (Q29) or short health status (Q1) assessments
* Legal blindness, as indicated on the on the health status (Q7) or short health status (Q2) assessments
* Hearing loss requiring hearing aids, as indicated on the health status (Q11) or short health status (Q3) assessments
* Composite cognitive score < 85 or composite language score < 85 on the Bayley III assessment; or cognition Mental Development Index (MDI) < 70 on the Bayley II assessment

If cognitive disability cannot be determined because the relevant Bayley III or Bayley II items are missing, the final criterion above can be replaced by any one of the following from the health status assessment:
* Uses less than 10 words (Q13); or language problems indicated on the short health assessment (Q4)
* Delayed development by more than 12 months (Q32)
* Other severe impairment (Q34)

If the infant does not meet any of the first three criteria, and all information on the Bayley assessment and these substitute criteria is also missing, the infant’s primary endpoint status will be missing.

.

Recruitment

Recruitment status

Stopped early

Date of first participant enrolment

Anticipated

1/08/2005

Actual

25/03/2006

Date of last participant enrolment

Anticipated

Actual

22/12/2010

Date of last data collection

Anticipated

Actual

30/09/2013

Sample size

Target

1200

Accrual to date

Final

1135

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

Taiwan, Province Of China

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC Grant

Country [1]

Australia

Primary sponsor type

Government body

Name

NHMRC Clinical Trials Centre

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Westmead Hospital

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/11/2005

Ethics approval number [1]

Ethics committee name [2]

Flinders Medical Centre

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

Ethics committee name [3]

Royal Women's Hospital

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

Ethics approval number [3]

Ethics committee name [4]

King Edward Memorial Hospital for Women

Ethics committee address [4]

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

Ethics approval number [4]

Summary

Brief summary

Oxygen is the commonest neonatal therapy. Unfortunately, both too much and too little oxygen may be harmful for very premature infants. We now measure the oxygen in a baby's blood by oxygen saturation but the optimum range in the first few weeks is unknown and no randomised controlled trial (RCT) has addressed this question. This proposal is for Australian arm of a major international study involving 5000 babies, born at less than 28 weeks, to address this question. Babies will be randomised to a higher or lower target range of oxygen saturation from birth (85-89% or 91-95%). For all oximeters staff will target a masked range of 88-92%. We will assess which of the two target ranges is associated with the best overall outcome, which is a composite measure of survival, disability on a standard test of neurodevelopment (Bayley scales), and visual function at 2 years of age.

Trial website

http://www.ctc.usyd.edu.au/BoostII/main_body/Home.htm

Public notes

Contacts

Principal investigator

Name

Prof William Tarnow-Mordi

Address

NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown
NSW1450
Australia

Country

Australia

Phone

+61 2 9562 5000

Email

[email protected]

Contact person for public queries

Name

Alpana Ghadge

Address

NHMRC Clinical Trials Centre
Locked Bag 77
Building F 88 Mallett Street
Camperdown Sydney NSW 2050

Country

Australia

Phone

+61 2 95625000

Email

[email protected]

Contact person for scientific queries

Name

Prof William Tarnow-Mordi

Address

Professor of Neonatal Medicine
NHMRC Clinical Trials Centre
University of Sydney
Camperdown
NSW 2050

Country

Australia

Phone

+61 2 98458900

Email

[email protected]

Source	Title	Year of Publication	DOI
Dimensions AI	Increased 36-Week Survival with High Oxygen Saturation Target in Extremely Preterm Infants	2011	https://doi.org/10.1056/nejmc1101319
Dimensions AI	NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol	2011	https://doi.org/10.1186/1471-2431-11-6
Embase	Optimal oxygenation of extremely low birth weight infants: A meta-analysis and systematic review of the oxygen saturation target studies.	2014	https://dx.doi.org/10.1159/000356561
Embase	Usual care and informed consent in clinical trials of oxygen management in extremely premature infants.	2016	https://dx.doi.org/10.1371/journal.pone.0155005

Trial Review

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