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Which oxygen saturation level should we use for very premature infants? A randomised controlled trial
ISRCTN ISRCTN00842661
DOI 10.1186/ISRCTN00842661
ClinicalTrials.gov identifier
EudraCT number
Public title Which oxygen saturation level should we use for very premature infants? A randomised controlled trial
Scientific title
Acronym BOOST-II UK
Serial number at source G0400415
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.
Lay summary Not provided at time of registration
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
Countries of recruitment Ireland, United Kingdom
Disease/condition/study domain Prematurity
Participants - 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
Participants - exclusion criteria Recruitment is not appropriate if there is no realistic prospect of survival, or follow-up is unlikely to be possible
Anticipated start date 01/04/2005
Anticipated end date 31/05/2014
Status of trial Completed
Patient information material Information leaflet for parents: http://www.npeu.ox.ac.uk/boost/downloads/boost_pil.pdf
Target number of participants 1200 (973 recruited by end of recruitment on 24/12/2010)
Interventions 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%.
Primary outcome measure(s) Death or serious neurosensory disability at 2 years corrected for prematurity
Secondary outcome measure(s) 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
Sources of funding Medical Research Council (UK)
Trial website http://www.npeu.ox.ac.uk/boost
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23642047
Contact name Dr  Peter  Brocklehurst
  Address NPEU
University of Oxford
Old Road Campus
  City/town Oxford
  Zip/Postcode OX3 7LF
  Country United Kingdom
  Tel +44 (0)1865 289719
  Fax +44 (0)1865 289720
  Email Peter.Brocklehurst@npeu.ox.ac.uk
Sponsor University of Oxford (UK)
  Address Kathryn Dally (Acting Head)
Medical Research Services Office
Medical School Office
Level 3
John Radcliffe Hospital
Headington
  City/town Oxford
  Zip/Postcode OX3 9DU
  Country United Kingdom
  Tel +44 (0)1865 289728
  Email Kathryn.Dally@admin.ox.ac.uk
Date applied 07/02/2006
Last edited 02/12/2013
Date ISRCTN assigned 23/03/2006
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