Hypoxia Clinical Trial
Official title:
Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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