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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01124331




Registration number
NCT01124331
Ethics application status
Date submitted
13/05/2010
Date registered
17/05/2010
Date last updated
13/03/2019

Titles & IDs
Public title
Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis
Scientific title
Appropriate Levels of Oxygen Saturation for Extremely Preterm Infants: Prospective Individual Patient Data Meta-analysis
Secondary ID [1] 0 0
NeOProM
Universal Trial Number (UTN)
Trial acronym
NeOProM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infant, Premature, Diseases 0 0
Bronchopulmonary Dysplasia 0 0
Retinopathy of Prematurity 0 0
Infant, Newborn, Diseases 0 0
Infant, Very Low Birth Weight 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Eye 0 0 0 0
Diseases / disorders of the eye
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Higher oxygen saturation target range (91%-95%)
Treatment: Surgery - Lower oxygen saturation (85%-89%)

Experimental: High Oxygen saturation - Higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol.

Active comparator: Lower oxygen saturation - Lower (SpO2 85-89%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol.


Treatment: Surgery: Higher oxygen saturation target range (91%-95%)
higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter

Treatment: Surgery: Lower oxygen saturation (85%-89%)
Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
composite outcome of death or major disability by 18-24 months corrected age
Timepoint [1] 0 0
by 18-24 months corrected age (gestational age plus chronological age)
Secondary outcome [1] 0 0
Retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy or anti-VEGF injection
Timepoint [1] 0 0
at 18-24 months corrected age
Secondary outcome [2] 0 0
measures of respiratory support
Timepoint [2] 0 0
36 weeks postmenstrual age
Secondary outcome [3] 0 0
Patent ductus arteriosus diagnosed by ultrasound and receiving medical treatment
Timepoint [3] 0 0
at 18-24 months corrected age
Secondary outcome [4] 0 0
Patent ductus arteriosus receiving surgical treatment
Timepoint [4] 0 0
at 18-24 months corrected age
Secondary outcome [5] 0 0
Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006)
Timepoint [5] 0 0
18-24 months corrected age
Secondary outcome [6] 0 0
Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006)
Timepoint [6] 0 0
at 36 weeks' postmenstrual age and discharge home
Secondary outcome [7] 0 0
Re-admissions to hospital
Timepoint [7] 0 0
up to 18-24 months postmenstrual age
Secondary outcome [8] 0 0
Cerebral palsy with GMFCS level 2 or higher or MACS level 2 or higher at 18-24 months corrected age
Timepoint [8] 0 0
at 18-24 months corrected age
Secondary outcome [9] 0 0
Severe visual impairment (cannot fixate or is legally blind:<6/60 vision , 1.3 logMAR in both eyes or equivalent as defined by trial)
Timepoint [9] 0 0
at 18-24 months corrected age
Secondary outcome [10] 0 0
deafness requiring hearing aids
Timepoint [10] 0 0
at 18-24 months corrected age
Secondary outcome [11] 0 0
Bayley-III Developmental Assessment cognitive score <85 and/or language score <85
Timepoint [11] 0 0
2 years corrected age
Secondary outcome [12] 0 0
death
Timepoint [12] 0 0
at 18-24 months corrected age

Eligibility
Key inclusion criteria
* Infants < 28wks gestation
Minimum age
No limit
Maximum age
24 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Infants > 28wks gestation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
4965
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital Women and Babies - Camperdown
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [5] 0 0
Royal North Shore Hospital, NSW - St Leonards
Recruitment hospital [6] 0 0
Westmead Hospital, - Westmead
Recruitment hospital [7] 0 0
Royal Brisbane Women's Hospital - Brisbane
Recruitment hospital [8] 0 0
Royal Women's Hospital - Melbourne
Recruitment hospital [9] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2310 - New Lambton
Recruitment postcode(s) [5] 0 0
- St Leonards
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
4006 - Brisbane
Recruitment postcode(s) [8] 0 0
3052 - Melbourne
Recruitment postcode(s) [9] 0 0
3800 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Otago
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Oxford
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Pennsylvania
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of California, San Diego
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
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)?
Trial website
https://clinicaltrials.gov/study/NCT01124331
Trial related presentations / publications
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.
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. Erratum In: JAMA. 2018 Jul 17;320(3):308. doi: 10.1001/jama.2018.9635.
Public notes

Contacts
Principal investigator
Name 0 0
Lisa Askie
Address 0 0
National Health and Medical Research Council, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01124331