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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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/ct2/show/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.
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