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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01124331
Other study ID # NeOProM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2005
Est. completion date August 2014

Study information

Verified date March 2019
Source University of Sydney
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 gestational age plus chronological age)?


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.


Recruitment information / eligibility

Status Completed
Enrollment 4965
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender All
Age group N/A to 24 Hours
Eligibility Inclusion Criteria:

- Infants < 28wks gestation

Exclusion Criteria:

- Infants > 28wks gestation

Study Design


Intervention

Procedure:
Higher oxygen saturation target range (91%-95%)
higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter
Lower oxygen saturation (85%-89%)
Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter

Locations

Country Name City State
Australia Royal Brisbane Women's Hospital Brisbane Queensland
Australia Royal Prince Alfred Hospital Women and Babies Camperdown New South Wales
Australia Canberra Hospital Canberra Australian Capital Territory
Australia Liverpool Hospital Liverpool New South Wales
Australia Monash Medical Centre Melbourne Victoria
Australia Royal Women's Hospital Melbourne Victoria
Australia John Hunter Hospital New Lambton New South Wales
Australia Royal North Shore Hospital, NSW St Leonards New South Wales
Australia Westmead Hospital, Westmead New South Wales

Sponsors (5)

Lead Sponsor Collaborator
University of Sydney University of California, San Diego, University of Otago, University of Oxford, University of Pennsylvania

Country where clinical trial is conducted

Australia, 

References & Publications (2)

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. — View 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Subgroup analyses will be undertaken on all pre-specified primary and secondary outcomes. Subgroups:
Gestational age
less than 26 weeks
greater than or equal to 26 weeks
Inborn or outborn
Use of any antenatal corticosteroids = yes if any of the following
incomplete, less than 24 hours before birth
complete
more than 7 days before birth
started less than 24h before birth
started 24h or more before birth
Male or female gender
Small for gestation age
birth weight below trialist defined cut-point
birth weight less than 10th percentile using WHO centile charts
Multiple or singleton birth
Mode of delivery
Vaginal if any of the following: vaginal, vaginal-cephalic, vaginal-breech
Caesarean if any of the following: caesarean, caesarean section before onset of labour, caesarean section after onset of labour, caesarean section
Time of intervention commencement
less than 6 hours after birth
6 hours or more after birth
Oximeter calibration software
original
revised
at 18-24 months corrected age
Primary 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
by 18-24 months corrected age (gestational age plus chronological age)
Secondary Retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy or anti-VEGF injection at 18-24 months corrected age
Secondary 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). 36 weeks postmenstrual age
Secondary Patent ductus arteriosus diagnosed by ultrasound and receiving medical treatment at 18-24 months corrected age
Secondary Patent ductus arteriosus receiving surgical treatment at 18-24 months corrected age
Secondary Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006) 18-24 months corrected age
Secondary Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006) at 36 weeks' postmenstrual age and discharge home
Secondary Re-admissions to hospital up to 18-24 months postmenstrual age
Secondary Cerebral palsy with GMFCS level 2 or higher or MACS level 2 or higher at 18-24 months corrected age at 18-24 months corrected age
Secondary Severe visual impairment (cannot fixate or is legally blind:<6/60 vision , 1.3 logMAR in both eyes or equivalent as defined by trial) at 18-24 months corrected age
Secondary deafness requiring hearing aids at 18-24 months corrected age
Secondary Bayley-III Developmental Assessment cognitive score <85 and/or language score <85 2 years corrected age
Secondary death at 18-24 months corrected age
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