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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by University of Sydney
Sponsor:
Collaborators:
University of Otago
University of Oxford
University of Pennsylvania
University of California, San Diego
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT01124331
First received: May 13, 2010
Last updated: January 15, 2012
Last verified: August 2011

May 13, 2010
January 15, 2012
March 2005
July 2013   (final data collection date for 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) ] [ Designated as safety issue: Yes ]

Major disability defined as having any of the following:

  • cognitive score < 85 on Bayley Scales of Infant Development (BSID) III
  • severe visual loss
  • cerebral palsy with inability to walk at 2yrs
  • deafness requiring hearing aids
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) ] [ Designated as safety issue: Yes ]

Major disability defined as having any of the following:

  • cognitive score < 70 on BSID-3
  • severe visual loss
  • cerebral palsy with inability to walk at 2yrs
  • deafness requiring hearing aids
Complete list of historical versions of study NCT01124331 on ClinicalTrials.gov Archive Site
  • retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy [ Time Frame: at 2 years corrected age ] [ Designated as safety issue: Yes ]
    ROP treatment by laser photocoagulation or cryotherapy is performed if Type I ROP or threshold ROP occurs
  • measures of respiratory support [ Time Frame: 36 weeks postmenstrual age ] [ Designated as safety issue: Yes ]
    measures of respiratory support, defined as (a) supplemental oxygen requirement at 36 weeks postmenstrual age, (b) days of endotracheal intubation (c) days of continuous positive airway pressure (CPAP), (d) days of supplemental oxygen, (e) days on home oxygen
  • patent ductus arteriosus [ Time Frame: at 2 years corrected age ] [ Designated as safety issue: Yes ]
    patent ductus arteriosus diagnosed by ultrasound and requiring medical treatment
  • patent ductus arteriosus requiring surgical treatment [ Time Frame: at 2 years corrected age ] [ Designated as safety issue: Yes ]
  • necrotising enterocolitis requiring surgery [ Time Frame: at 2 years corrected age ] [ Designated as safety issue: Yes ]
  • weight [ Time Frame: at birth, 36 weeks postmenstrual age, discharge home and 18-24 months corrected age ] [ Designated as safety issue: No ]
  • re-admissions to hospital [ Time Frame: up to 18-24 months postmenstrual age ] [ Designated as safety issue: Yes ]
  • cerebral palsy with Gross Motor Function Classification System (GMFCS) level 2 or higher or Manual Ability Classification System (MACS) level 2 or higher [ Time Frame: at 18-24 months corrected age ] [ Designated as safety issue: Yes ]
  • blindness [ Time Frame: 2 years corrected age ] [ Designated as safety issue: Yes ]
    defined as <6/60 vision, 1.3 logMAR in both eyes
  • deafness requiring hearing aids [ Time Frame: 2 years corrected age ] [ Designated as safety issue: Yes ]
  • quantitative Bayley III scores [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
  • death [ Time Frame: 2 years corrected age ] [ Designated as safety issue: Yes ]
  • retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy [ Time Frame: at 2 years corrected age ] [ Designated as safety issue: Yes ]
    ROP treatment by laser photocoagulation or cryotherapy is performed if Type I ROP or threshold ROP occurs
  • measures of respiratory support [ Time Frame: 36 weeks postmenstrual age ] [ Designated as safety issue: Yes ]
    measures of respiratory support, defined as (a) supplemental oxygen requirement at 36 weeks postmenstrual age, (b) days of endotracheal intubation (c) days of CPAP, (d) days of supplemental oxygen, (e) days on home oxygen
  • patent ductus arteriosus [ Time Frame: at 2 years corrected age ] [ Designated as safety issue: Yes ]
    patent ductus arteriosus diagnosed by ultrasound and requiring medical treatment
  • patent ductus arteriosus requiring surgical treatment [ Time Frame: at 2 years corrected age ] [ Designated as safety issue: Yes ]
  • necrotising enterocolitis requiring surgery [ Time Frame: at 2 years corrected age ] [ Designated as safety issue: Yes ]
  • weight [ Time Frame: at birth, 36 weeks postmenstrual age, discharge home and 18-24 months corrected age ] [ Designated as safety issue: No ]
  • re-admissions to hospital [ Time Frame: up to 18-24 months postmenstrual age ] [ Designated as safety issue: Yes ]
  • cerebral palsy with GMFCS level 2 or higher or MACS level 2 or higher [ Time Frame: at 18-24 months corrected age ] [ Designated as safety issue: Yes ]
  • blindness [ Time Frame: 2 years corrected age ] [ Designated as safety issue: Yes ]
    defined as <3/60 vision, 1.3 logMAR in both eyes
  • deafness requiring hearing aids [ Time Frame: 2 years corrected age ] [ Designated as safety issue: Yes ]
  • quantitative Bayley III scores [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
  • death [ Time Frame: 2 years corrected age ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective Meta-analysis
Appropriate Levels of Oxygen Saturation for Extremely Preterm Infants: Prospective Individual Patient Data Meta-analysis

For over 60 years the most appropriate oxygen level for preterm babies remains unknown. To answer this, we will combine data from over 5300 babies to be sure the expected benefits of lower oxygen for babies' eyes and lungs does not come at the expense of increasing death or major disability in these children. Planning to do this before the results of any of the trials are known is called a prospective meta-analysis. This is the first time this technique has been used in neonatal medicine.

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 over 5,300 enrolled infants.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Infant, Premature, Diseases
  • Bronchopulmonary Dysplasia
  • Retinopathy of Prematurity
  • Infant, Newborn, Diseases
  • Infant, Very Low Birth Weight
  • Procedure: Higher oxygen saturation target range (91%-95%)
    higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter
  • Procedure: Lower oxygen saturation (85%-89%)
    Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter
  • Experimental: High Oxygen saturation
    Higher oxygen saturation (91%-95%)
    Intervention: Procedure: Higher oxygen saturation target range (91%-95%)
  • Active Comparator: Lower oxygen saturation
    Lower oxygen saturation (85%-89%)
    Intervention: Procedure: Lower oxygen saturation (85%-89%)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5230
April 2015
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infants < 28wks gestation

Exclusion Criteria:

  • Infants > 28wks gestation
Both
up to 24 Hours
No
Contact: Lisa Askie +61 2 9562 5000
Australia
 
NCT01124331
NeOProM
Yes
Dr Lisa Askie, NHMRC Clinical Trials Centre, University of Sydney
University of Sydney
  • University of Otago
  • University of Oxford
  • University of Pennsylvania
  • University of California, San Diego
Principal Investigator: Lisa Askie NHMRC Clinical Trials Centre, University of Sydney
University of Sydney
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP