Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis

Bronchopulmonary Dysplasia Clinical Trial

— NeOProM  

Official title:

Appropriate Levels of Oxygen Saturation for Extremely Preterm Infants: Prospective Individual Patient Data Meta-analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124331
• Other study ID #: NeOProM
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Birth Weight
• Bronchopulmonary Dysplasia
• Infant, Newborn, Diseases
• Infant, Premature, Diseases
• Infant, Very Low Birth Weight
• Retinopathy of Prematurity

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