Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study
Condition: Infant, Newborn, Diseases; Hypoxia
MeSH terms: Infant, Newborn, Diseases; Hypoxia
Study type: Interventional

Summary: 
      The purpose of this study is to determine if, in preterm infants < 37 weeks' gestation at
      birth receiving oxygen without ventilatory/CPAP support, oxygen environment (OE) compared
      with nasal cannula oxygen (NC), will decrease the number of episodes with oxygen saturations
      less than 85% of ≥10 seconds in a 48 hour cross over period on either intervention.

      This is a randomized cross-over pilot study with a 1:1 parallel allocation of infants to
      oxygen environment or nasal cannula oxygen using stratified permuted block design. Following
      a 24 hour period on the first intervention, infants will cross over to a 24 hour period on
      the second (alternative) intervention before crossing back to the first intervention for a
      further 24 hours and then back again to the second (alternative) intervention for a further
      24 hours.
    

Detailed description: 
      In preterm infants < 37 weeks' gestation at birth requiring oxygen without ventilatory/CPAP
      support, will oxygen environment decrease the number of episodes with oxygen saturations less
      than 85% for ≥ 10 seconds in a 48 hour cross-over period on either intervention compared with
      nasal cannula oxygen?

      The target oxygen saturations (91 to 95%) are based on data from the meta-analysis of
      randomized controlled trials of oxygen saturation targets which included data on 4911 infants
      from the SUPPORT, COT, and BOOST II trials.

      This study will include preterm infants < 37 weeks' gestation on oxygen therapy via OE or NC
      with flow rates ≤ 1.0 l/kg/min. There will be three randomization strata [≥ 22+0/7 to ≤
      25+6/7 weeks, ≥ 26+0/7 to ≤ 28+6/7 weeks, ≥ 29+0/7 to ≤ 36+6/7 weeks' gestation]. The purpose
      of stratification is to ensure an appropriate distribution of risk between study arms. This
      study will not be powered to detect outcome differences within or between strata.

      Following informed consent, randomization, stratified by gestational age at delivery, will be
      performed using sequentially numbered sealed opaque envelopes. Each envelope will indicate
      either Treatment group (OE group) or Control group (NC group). The envelope will only be
      opened after informed consent has been obtained and just before starting the study on each
      infant.

      This will be a single center randomized cross-over pilot study with a 1:1 parallel allocation
      of infants to oxygen environment or nasal cannula oxygen using stratified permuted block
      design. Following a 24 hour period on the first intervention and a 15-30 minute washout
      period, infants will cross-over to a 24 hour period of the second/alternate intervention.
      Following a further 15-30 minute washout period, infants will cross-over to a 24 hour period
      on the first intervention. Following another 15-30 minute washout period, infants will
      cross-over to a 24 hour period on the second/alternate intervention. The effective FiO2 will
      be calculated for all infants based on their oxygen therapy modality prior to the monitoring
      period and used to swap between modes.

      All infants enrolled in the study will have routine monitoring, uniform target saturation
      ranges of 91-95% with alarm limits set at 88-95%, and standard care for the duration of the
      study. Pulse oximetry recordings will be downloaded using ixTrend (iexcellence, Wildau,
      Germany) software to a secure computer system for later data analysis.

      Infants will continue standard treatment as recommended by the treating physician and will
      act as their own controls.

      Primary secondary outcomes are described below. Other safety outcomes include recordings of
      episodes of bradycardia and circumstances surrounding the event.

      Pulse oximetry recordings will be downloaded using ixTrend software to a secure computer
      system for later data analysis.
    

Intervention name(s): Oxygen Environment; Nasal Cannula Oxygen
Intervention type(s): Procedure; Procedure
Intervention description(s): FiO2 delivered by servo-controlled incubator; FiO2 delivered by nasal cannula
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oxygen Delivery System, Nasal Cannula; Oxygen Delivery System, Incubator