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

This study has been completed.
Sponsor:
Collaborators:
University of Otago
University of Oxford
University of Pennsylvania
University of California, San Diego
Information provided by (Responsible Party):
University of Sydney
ClinicalTrials.gov Identifier:
NCT01124331
First received: May 13, 2010
Last updated: February 3, 2015
Last verified: February 2015
  Purpose

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)?


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:


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 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


Secondary Outcome Measures:
  • Retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy or anti-VEGF injection [ Time Frame: at 18-24 months corrected age ] [ Designated as safety issue: Yes ]
  • measures of respiratory support [ Time Frame: 36 weeks postmenstrual age ] [ Designated as safety issue: Yes ]
    • 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).

  • Patent ductus arteriosus diagnosed by ultrasound and receiving medical treatment [ Time Frame: at 18-24 months corrected age ] [ Designated as safety issue: Yes ]
  • Patent ductus arteriosus receiving surgical treatment [ Time Frame: at 18-24 months corrected age ] [ Designated as safety issue: Yes ]
  • Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006) [ Time Frame: 18-24 months corrected age ] [ Designated as safety issue: Yes ]
  • 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 ] [ 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 at 18-24 months corrected age [ Time Frame: at 18-24 months corrected age ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • deafness requiring hearing aids [ Time Frame: at 18-24 months corrected age ] [ Designated as safety issue: Yes ]
  • Bayley-III Developmental Assessment cognitive score <85 and/or language score <85 [ Time Frame: 2 years corrected age ] [ Designated as safety issue: No ]
  • death [ Time Frame: at 18-24 months corrected age ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Subgroup analyses will be undertaken on all pre-specified primary and secondary outcomes. [ Time Frame: at 18-24 months corrected age ] [ Designated as safety issue: Yes ]

    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


Enrollment: 4959
Study Start Date: March 2005
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Oxygen saturation
Higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol.
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 (SpO2 85-89%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol.
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 almost 5000 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124331

Locations
Australia, Australian Capital Territory
Canberra Hospital
Canberra, Australian Capital Territory, Australia
Australia, New South Wales
Royal Prince Alfred Hospital Women and Babies
Camperdown, New South Wales, Australia, 2050
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
John Hunter Hospital
New Lambton, New South Wales, Australia, 2310
Royal North Shore Hospital, NSW
St Leonards, New South Wales, Australia
Westmead Hospital,
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane Women's Hospital
Brisbane, Queensland, Australia, 4006
Australia, Victoria
Monash Medical Centre
Melbourne, Victoria, Australia, 3800
Royal Women's Hospital
Melbourne, Victoria, Australia, 3052
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

Publications:
Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT01124331     History of Changes
Other Study ID Numbers: NeOProM
Study First Received: May 13, 2010
Last Updated: February 3, 2015
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
Retinopathy of Prematurity
Body Weight
Eye Diseases
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Retinal Diseases
Signs and Symptoms
Ventilator-Induced Lung Injury

ClinicalTrials.gov processed this record on April 30, 2015