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Completed

NCT Number: NCT01124331

Appropriate Oxygen Levels for Extremely Preterm Infants: a Prospective 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)?

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Key information

Conditions

Infant, Premature, Diseases Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Very Low Birth Weight Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Retinal Diseases Retinopathy of Prematurity Urogenital Diseases Ventilator-Induced Lung Injury

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canberra Hospital, Canberra, Australian Capital Territory, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants < 28wks gestation

Exclusion criteria

  • Infants > 28wks gestation

Treatment and study plan

Higher oxygen saturation target range (91%-95%)

Procedure

higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter

Lower oxygen saturation (85%-89%)

Procedure

Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter

Primary outcomes

  1. 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)

    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 outcomes

  1. Retinopathy of prematurity (ROP) treatment by laser photocoagulation or cryotherapy or anti-VEGF injection

    Time frame: at 18-24 months corrected age

  2. measures of respiratory support

    Time frame: 36 weeks postmenstrual age

    • 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).

  3. Patent ductus arteriosus diagnosed by ultrasound and receiving medical treatment

    Time frame: at 18-24 months corrected age

  4. Patent ductus arteriosus receiving surgical treatment

    Time frame: at 18-24 months corrected age

  5. Weight z-score based on WHO percentile charts (WHO Multicentre Growth Reference Study Group, 2006)

    Time frame: 18-24 months corrected age

  6. 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

  7. Re-admissions to hospital

    Time frame: up to 18-24 months postmenstrual age

  8. 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

  9. 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

  10. deafness requiring hearing aids

    Time frame: at 18-24 months corrected age

  11. Bayley-III Developmental Assessment cognitive score <85 and/or language score <85

    Time frame: 2 years corrected age

  12. death

    Time frame: at 18-24 months corrected age

Other outcomes

  1. Subgroup analyses will be undertaken on all pre-specified primary and secondary outcomes.

    Time frame: at 18-24 months corrected age

    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

Sponsors and collaborators

Lead sponsor

University of Sydney

Other

Collaborators

  • University of California, San Diego
  • University of Otago
  • University of Oxford
  • University of Pennsylvania

Registry information

Official study title

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

Acronym: NeOProM

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
May 17, 2010
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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