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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention
Infant, Premature, Diseases
Bronchopulmonary Dysplasia
Retinopathy of Prematurity
Infant, Newborn, Diseases
Infant, Very Low Birth Weight
 Procedure: Higher oxygen saturation target range (91%-95%)
Procedure: Lower oxygen saturation (85%-89%)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Appropriate Levels of Oxygen Saturation for Extremely Preterm Infants: Prospective Individual Patient Data Meta-analysis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 5230
Study Start Date: March 2005
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Oxygen saturation
Higher oxygen saturation (91%-95%)
 Procedure: Higher oxygen saturation target range (91%-95%)
higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter
Active Comparator: Lower oxygen saturation
Lower oxygen saturation (85%-89%)
 Procedure: Lower oxygen saturation (85%-89%)
Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter

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 over 5,300 enrolled infants.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants < 28wks gestation

Exclusion Criteria:

  • Infants > 28wks gestation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124331

Contacts
Contact: Lisa Askie +61 2 9562 5000

Locations
Australia, Australian Capital Territory
Canberra Hospital Recruiting
Canberra, Australian Capital Territory, Australia
Australia, New South Wales
Royal Prince Alfred Hospital Women and Babies Recruiting
Camperdown, New South Wales, Australia, 2050
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
John Hunter Hospital Recruiting
New Lambton, New South Wales, Australia, 2310
Royal North Shore Hospital, NSW Recruiting
St Leonards, New South Wales, Australia
Westmead Hospital, Recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane Women's Hospital Recruiting
Brisbane, Queensland, Australia, 4006
Australia, Victoria
Royal Women's Hospital Recruiting
Melbourne, Victoria, Australia, 3052
Monash Medical Centre Recruiting
Melbourne, Victoria, Australia, 3800
Sponsors and Collaborators
University of Sydney
University of Otago
University of Oxford
University of Pennsylvania
University of California, San Diego
Investigators
Principal Investigator: Lisa Askie NHMRC Clinical Trials Centre, University of Sydney
  More Information

No publications provided by University of Sydney

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr Lisa Askie, NHMRC Clinical Trials Centre, University of Sydney
ClinicalTrials.gov Identifier: NCT01124331     History of Changes
Other Study ID Numbers: NeOProM
Study First Received: May 13, 2010
Last Updated: January 15, 2012
Health Authority: Australia: National Health and Medical Research Council
United Kingdom: National Health Service
Canada: Ethics Review Committee
United States: Institutional Review Board

Keywords provided by University of Sydney:
prospective meta-analysis
preterm infant
pulse oximetry
oxygen saturation

Additional relevant MeSH terms:
Birth Weight
Bronchopulmonary Dysplasia
Infant, Newborn, Diseases
Infant, Premature, Diseases
Retinal Diseases
Retinopathy of Prematurity
Body Weight
 Signs and Symptoms
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013