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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

May 13, 2010
February 3, 2015
March 2005
August 2014   (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 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
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 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 ]
  • 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 ]
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
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
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)?

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.

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 (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter, for durations as specified in each trial protocol.
    Intervention: Procedure: Higher oxygen saturation target range (91%-95%)
  • 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.
    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.
 
Completed
4959
August 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infants < 28wks gestation

Exclusion Criteria:

  • Infants > 28wks gestation
Both
up to 24 Hours   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01124331
NeOProM
Yes
Not Provided
Not Provided
University of Sydney
University of Sydney
  • University of Otago
  • University of Oxford
  • University of Pennsylvania
  • University of California, San Diego
Principal Investigator: Lisa Askie National Health and Medical Research Council, Australia
University of Sydney
February 2015

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