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14 March 2010
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| [ Print-friendly version ] |
| Which oxygen saturation level should we use for very premature infants? A randomised controlled trial |
| ISRCTN | ISRCTN00842661 |
| ClinicalTrials.gov identifier | |
| 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? |
| Ethics approval | Added as of 27/07/2007: Trent Multi-Centre Ethics Committee, approved on 2nd May 2007 (ref: 06/MRE04/91) |
| Study design | Double-blind randomised controlled trial |
| Countries of recruitment | 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 | 30/11/2013 |
| Status of trial | Ongoing |
| Patient information material | Information leaflet for parents: http://www.npeu.ox.ac.uk/boost/downloads/boost_pil.pdf |
| Target number of participants | 1200 |
| 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 | |
| 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 |
| 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 |
| Kathryn.Dally@admin.ox.ac.uk | |
| Date applied | 07/02/2006 |
| Last edited | 17/07/2009 |
| Date ISRCTN assigned | 23/03/2006 |
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