Condition category
Neonatal Diseases
Date applied
07/02/2006
Date assigned
23/03/2006
Last edited
02/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.npeu.ox.ac.uk/boost

Contact information

Type

Scientific

Primary contact

Dr Peter Brocklehurst

ORCID ID

Contact details

NPEU
University of Oxford
Old Road Campus
Oxford
OX3 7LF
United Kingdom
+44 (0)1865 289719
Peter.Brocklehurst@npeu.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0400415

Study information

Scientific title

Acronym

BOOST-II UK

Study hypothesis

Does varying the concentration of inspired oxygen so as to target a low (85-89%) versus a high (91-95%) functional arterial oxygen saturation (SpO2), from the day of birth until the baby is breathing air (or until the baby has reached a postmenstrual age of at least 36 weeks) affect the incidence of:
1. Retinopathy of prematurity (plus disease or Grade 3 and 4) and its two year outcome?
2. Other surgery (for conditions such as patent ductus arteriosus, post-haemorrhagic ventriculomegaly or necrotising enterocolitis)?
3. Chronic lung disease?
4. Death or severe neurosensory disability on assessment 2 years after the child was due to be born?
5. Poor weight gain and head growth between birth and 36 weeks postmenstrual age, and between birth and 2 years of age?

As of 06/12/2012, the following updates were added to the record:
1. Ireland was added to the countries of recruitment.
2. The trial is now in follow-up; recruitment ended on 24/12/2010.

As of 02/12/2013, the anticipated end date was changed from 30/11/2013 to 31/05/2014.

Ethics approval

Added as of 27/07/2007: Trent Multi-Centre Ethics Committee, 02/05/2007, ref: 06/MRE04/91

Study design

Double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Information leaflet for parents: http://www.npeu.ox.ac.uk/boost/downloads/boost_pil.pdf

Condition

Prematurity

Intervention

The intervention is to maintain functional oxygen saturations in the range 85-89% or 91-95%. Masimo radical oximeters (Irvine, CA) will be used to monitor oxygen saturation levels. The oximeters will be modified to display and store a figure that is either 3% above or 3% below the 'true' oxygen saturation between 85% and 95% as computed by the machines' internal algorithm. Outside of these limits the oximeter will display the true value. Staff will aim for an oximeter reading of between 88 and 92%. This will, therefore, generate two trial groups: one for which oxygen saturation is maintained at 85-89%, and one for which it is maintained at 91-95%.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Death or serious neurosensory disability at 2 years corrected for prematurity

Secondary outcome measures

1. Respiratory outcomes:
a. Days of endotracheal intubation
b. Days of nasal continuous positive airway pressure
c. Supplemental oxygen at a postmenstrual age of 36 weeks
d. Days of oxygen prior to home discharge
e. Days in oxygen after home discharge
2. Retinopathy of prematurity (ROP), plus disease, stage 3 and 4 disease
3. Patent ductus arteriosus requiring medical or surgical treatment
4. Necrotising enterocolitis, Bell stage 3 or 4
5. Changes in weight and head circumference from birth to 36 weeks postmenstrual age, and 2 years after delivery was due
6. Retinal structure when last seen for ophthalmic review; outcomes at age 2 years
7. Re-admissions to hospital until 2 years after delivery was due (and their cause)
8. Cerebral palsy (and its severity)
9. Visual disability
10. Deafness
11. Developmental delay using the Bayley Test Mental Developmental Index (MDI)
12. Other disability not classifiable as neurosensory in origin
13. All postneonatal (>27 days) deaths, together with their immediate and underlying cause

Overall trial start date

01/04/2005

Overall trial end date

31/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Infants are eligible if they are:
1. Less than 28 weeks gestation at birth
2. Less than 12 h old (24 h if the baby is outborn)
3. The clinician and parents are substantially uncertain which SpO2 is better

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

1200 (973 recruited by end of recruitment on 24/12/2010)

Participant exclusion criteria

Recruitment is not appropriate if there is no realistic prospect of survival, or follow-up is unlikely to be possible

Recruitment start date

01/04/2005

Recruitment end date

31/05/2014

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

NPEU
Oxford
OX3 7LF
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Kathryn Dally (Acting Head)
Medical Research Services Office
Medical School Office
Level 3
John Radcliffe Hospital
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 289728
Kathryn.Dally@admin.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23642047

Publication citations

  1. Results

    , , , Stenson BJ, Tarnow-Mordi WO, Darlow BA, Simes J, Juszczak E, Askie L, Battin M, Bowler U, Broadbent R, Cairns P, Davis PG, Deshpande S, Donoghoe M, Doyle L, Fleck BW, Ghadge A, Hague W, Halliday HL, Hewson M, King A, Kirby A, Marlow N, Meyer M, Morley C, Simmer K, Tin W, Wardle SP, Brocklehurst P, Oxygen saturation and outcomes in preterm infants., N. Engl. J. Med., 2013, 368, 22, 2094-2104, doi: 10.1056/NEJMoa1302298.

Additional files

Editorial Notes