Clinical trial NCT01124331: Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis
Official title: Appropriate Levels of Oxygen Saturation for Extremely Preterm Infants: Prospective Individual Patient Data Meta-analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature, Diseases
Bronchopulmonary Dysplasia
Retinopathy of Prematurity
Infant, Newborn, Diseases
Infant, Very Low Birth Weight
Keywords: prospective meta-analysis
preterm infant
pulse oximetry
oxygen saturation
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: University of Otago
name: University of Oxford
name: University of Pennsylvania
name: University of California, San Diego
First posted: 2010-05-17
Enrollment: 4965
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary question to be addressed by this study is: compared with a functional oxygen saturation level (SpO2) of 91-95%, does targeting SpO2 85-89% in extremely preterm infants from birth or soon after, result in a difference in mortality or major disability in survivors by 2 years corrected age (defined as gestational age plus chronological age)?

Detailed description: Oxygen has been used in the care of small and sick newborn babies for over 60 years. However, to date there has been no reliable evidence to guide clinicians regarding what is the best level to target oxygen saturation in preterm infants to balance the four competing risks of mortality, lung disease, eye damage and developmental disability.

Five high quality randomised controlled trials are now underway assessing two different levels of oxygen saturation targeting (USA - SUPPORT; Australia - BOOST II; New Zealand - BOOST NZ; UK - BOOST II UK; Canada - COT). The value of these gold-standard trials can be further enhanced when, with careful planning, they are synthesised into a prospective meta-analysis (PMA). A PMA is one where trials are identified for inclusion in the analysis before any of the individual results are known.

We have established the Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration, comprising the investigators of these five trials and a methodology team. The trials are sufficiently similar with respect to design, participants and intervention and, with planning, will have enough common outcome measures to enable their results to be prospectively meta-analysed. Together they have a combined sample size of almost 5000 enrolled infants.

Eligibility criteria: Inclusion Criteria:

* Infants \< 28wks gestation

Exclusion Criteria:

* Infants \> 28wks gestation

Primary outcomes:
measure: composite outcome of death or major disability by 18-24 months corrected age
timeFrame: by 18-24 months corrected age (gestational age plus chronological age)
Secondary outcomes:
measure: Retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy or anti-VEGF injection
timeFrame: at 18-24 months corrected age
measure: measures of respiratory support
timeFrame: 36 weeks postmenstrual age
measure: Patent ductus arteriosus diagnosed by ultrasound and receiving medical treatment
timeFrame: at 18-24 months corrected age
measure: Patent ductus arteriosus receiving surgical treatment
timeFrame: at 18-24 months corrected age
measure: Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006)
timeFrame: 18-24 months corrected age
measure: Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006)
timeFrame: at 36 weeks' postmenstrual age and discharge home
measure: Re-admissions to hospital
timeFrame: up to 18-24 months postmenstrual age
measure: Cerebral palsy with GMFCS level 2 or higher or MACS level 2 or higher at 18-24 months corrected age
timeFrame: at 18-24 months corrected age
measure: Severe visual impairment (cannot fixate or is legally blind:<6/60 vision , 1.3 logMAR in both eyes or equivalent as defined by trial)
timeFrame: at 18-24 months corrected age
measure: deafness requiring hearing aids
timeFrame: at 18-24 months corrected age
measure: Bayley-III Developmental Assessment cognitive score <85 and/or language score <85
timeFrame: 2 years corrected age
measure: death
timeFrame: at 18-24 months corrected age
Other outcomes:
measure: Subgroup analyses will be undertaken on all pre-specified primary and secondary outcomes.
timeFrame: at 18-24 months corrected age
Locations:
city: Canberra
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital Women and Babies
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: New Lambton
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital, NSW
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital,
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane Women's Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Royal Women's Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
Study officials:
affiliation: National Health and Medical Research Council, Australia
name: Lisa Askie
role: PRINCIPAL_INVESTIGATOR
References:
citation: Askie LM, Brocklehurst P, Darlow BA, Finer N, Schmidt B, Tarnow-Mordi W; NeOProM Collaborative Group. NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol. BMC Pediatr. 2011 Jan 17;11:6. doi: 10.1186/1471-2431-11-6.
citation: Askie LM, Darlow BA, Finer N, Schmidt B, Stenson B, Tarnow-Mordi W, Davis PG, Carlo WA, Brocklehurst P, Davies LC, Das A, Rich W, Gantz MG, Roberts RS, Whyte RK, Costantini L, Poets C, Asztalos E, Battin M, Halliday HL, Marlow N, Tin W, King A, Juszczak E, Morley CJ, Doyle LW, Gebski V, Hunter KE, Simes RJ; Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration. Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA. 2018 Jun 5;319(21):2190-2201. doi: 10.1001/jama.2018.5725.