Infant, Premature, DiseasesNeOProMNCT01124331
Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis
A study testing Higher oxygen saturation target range (91%-95%) and Lower oxygen saturation (85%-89%) in people with Infant, Premature, Diseases and Bronchopulmonary Dysplasia, run by University of Sydney at 9 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Retinopathy of Prematurity
- What is being tested?
- Higher oxygen saturation target range (91%-95%) and Lower oxygen saturation (85%-89%)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,965 participants
- Where
- 9 sitesAustralia
- Study dates
- Mar 2005to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants < 28wks gestation
Who cannot join
- Infants > 28wks gestation
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Australia9 sites
Royal Brisbane Women's Hospital
Brisbane, Queensland, 4006
Royal Prince Alfred Hospital Women and Babies
Camperdown, New South Wales, 2050
Canberra Hospital
Canberra, Australian Capital Territory
Liverpool Hospital
Liverpool, New South Wales, 2170
Royal Women's Hospital
Melbourne, Victoria, 3052
Monash Medical Centre
Melbourne, Victoria, 3800
John Hunter Hospital
New Lambton, New South Wales, 2310
Royal North Shore Hospital, NSW
St Leonards, New South Wales
Westmead Hospital,
Westmead, New South Wales, 2145
About this study
Official title: Appropriate Levels of Oxygen Saturation for Extremely Preterm Infants: Prospective Individual Patient Data Meta-analysis
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)?
Read the 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.
- Conditions
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Infant, Newborn, Diseases, Infant, Very Low Birth Weight
- Being tested
- Higher oxygen saturation target range (91%-95%), Lower oxygen saturation (85%-89%)
- Keywords
- prospective meta-analysis, preterm infant, pulse oximetry, oxygen saturation
- Medical subject headings
- Infant, Premature, Diseases, Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Infant, Newborn, Diseases, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher oxygen saturation target range (91%-95%)Procedure or surgery
higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter
Lower oxygen saturation (85%-89%)Procedure or surgery
Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter
| Study group | Role | What they receive |
|---|---|---|
| High Oxygen saturation | Experimental | Higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol. Receives: Procedure: Higher oxygen saturation target range (91%-95%) |
| Lower oxygen saturation | Active comparator | Lower (SpO2 85-89%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol. Receives: Procedure: Lower oxygen saturation (85%-89%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite outcome of death or major disability by 18-24 months corrected age
Major disability is defined as any of the following:
- Bayley-III Developmental Assessment cognitive score <85 and/or language score <85
- Severe visual loss
- Cerebral palsy with Gross Motor Function Classification System (GMFCS) level 2 or higher or Manual Ability Classification System (MACS) level 2 or higher at 18-24 months postmenstrual age
- Deafness requiring hearing aids
Measured: by 18-24 months corrected age (gestational age plus chronological age)
Secondary outcomes (12)
Retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy or anti-VEGF injection
Measured: at 18-24 months corrected age
measures of respiratory support
- Measures of respiratory support, including the following separate outcomes a. supplemental oxygen requirement at 36 weeks postmenstrual age, b. postmenstrual age ceased endotracheal intubation, c. postmenstrual age ceased continuous positive airway pressure (CPAP), d. postmenstrual age ceased supplemental oxygen, e. postmenstrual age ceased home oxygen (if received).
Measured: 36 weeks postmenstrual age
Patent ductus arteriosus diagnosed by ultrasound and receiving medical treatment
Measured: at 18-24 months corrected age
Patent ductus arteriosus receiving surgical treatment
Measured: at 18-24 months corrected age
Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006)
Measured: 18-24 months corrected age
Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006)
Measured: at 36 weeks' postmenstrual age and discharge home
Re-admissions to hospital
Measured: up to 18-24 months postmenstrual age
Cerebral palsy with GMFCS level 2 or higher or MACS level 2 or higher at 18-24 months corrected age
Measured: at 18-24 months corrected age
Severe visual impairment (cannot fixate or is legally blind:<6/60 vision , 1.3 logMAR in both eyes or equivalent as defined by trial)
Measured: at 18-24 months corrected age
deafness requiring hearing aids
Measured: at 18-24 months corrected age
Bayley-III Developmental Assessment cognitive score <85 and/or language score <85
Measured: 2 years corrected age
death
Measured: at 18-24 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startMar 2005
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,965 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- University of Otago, University of Oxford, University of Pennsylvania, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Lisa Askie, Principal investigator, National Health and Medical Research Council, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124331
- Sponsor's protocol ID
- NeOProM
- Acronym
- NeOProM
- Status last verified
- Mar 2019
- First submitted
- 13 May 2010
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 21235822Askie 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.
PubMed 29872859
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Levels of Oxygen Saturation for Extremely Preterm Infants: Prospective Individual Patient Data Meta-analysis
- ClinicalTrials.gov ID
- NCT01124331
- Acronym / sponsor ID
- NeOProM / NeOProM
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,965 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- University of Otago, University of Oxford, University of Pennsylvania, University of California, San Diego
- Study start
- Mar 2005
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Oxygen saturation | Experimental | Procedure: Higher oxygen saturation target range (91%-95%)Higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol. |
| Lower oxygen saturation | Active comparator | Procedure: Lower oxygen saturation (85%-89%)Lower (SpO2 85-89%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol. |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants < 28wks gestation
Key exclusion criteria (1 listed)
- Infants > 28wks gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Higher oxygen saturation target range (91%-95%)higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter | Procedure or surgery | High Oxygen saturation |
| Lower oxygen saturation (85%-89%)Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter | Procedure or surgery | Lower oxygen saturation |
Primary outcome
composite outcome of death or major disability by 18-24 months corrected age
Time frame: by 18-24 months corrected age (gestational age plus chronological age)
Major disability is defined as any of the following: * Bayley-III Developmental Assessment cognitive score <85 and/or language score <85 * Severe visual loss * Cerebral palsy with Gross Motor Function Classification System (GMFCS) level 2 or higher or Manual Ability Classification System (MACS) level 2 or higher at 18-24 months postmenstrual age * Deafness requiring hearing aids
12 secondary outcomes
Retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy or anti-VEGF injection
Time frame: at 18-24 months corrected age
measures of respiratory support
Time frame: 36 weeks postmenstrual age
Patent ductus arteriosus diagnosed by ultrasound and receiving medical treatment
Time frame: at 18-24 months corrected age
Patent ductus arteriosus receiving surgical treatment
Time frame: at 18-24 months corrected age
Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006)
Time frame: 18-24 months corrected age
Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006)
Time frame: at 36 weeks' postmenstrual age and discharge home
Re-admissions to hospital
Time frame: up to 18-24 months postmenstrual age
Cerebral palsy with GMFCS level 2 or higher or MACS level 2 or higher at 18-24 months corrected age
Time frame: at 18-24 months corrected age
Severe visual impairment (cannot fixate or is legally blind:<6/60 vision , 1.3 logMAR in both eyes or equivalent as defined by trial)
Time frame: at 18-24 months corrected age
deafness requiring hearing aids
Time frame: at 18-24 months corrected age
Bayley-III Developmental Assessment cognitive score <85 and/or language score <85
Time frame: 2 years corrected age
death
Time frame: at 18-24 months corrected age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Background: PubMed 21235822Askie 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.
- Results publication: PubMed 29872859Askie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Askie principal investigator
National Health and Medical Research Council, Australia
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Higher oxygen saturation target range (91%-95%) and Lower oxygen saturation (85%-89%) in people with Infant, Premature, Diseases and Bronchopulmonary Dysplasia, run by University of Sydney at 9 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite outcome of death or major disability by 18-24 months corrected age (time frame: by 18-24 months corrected age (gestational age plus chronological age)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01124331, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.