Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study
NCT ID: NCT02794662
Last Updated: 2016-12-01
Study Results
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Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2016-04-30
2016-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Oxygen Environment
Blended oxygen delivered by servo-controlled incubator
Oxygen Environment
FiO2 delivered by servo-controlled incubator
Nasal cannula oxygen
Blended oxygen delivered by nasal cannula
Nasal Cannula Oxygen
FiO2 delivered by nasal cannula
Interventions
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Oxygen Environment
FiO2 delivered by servo-controlled incubator
Nasal Cannula Oxygen
FiO2 delivered by nasal cannula
Eligibility Criteria
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Inclusion Criteria
* Off ventilatory support and/or NCPAP for \> 48 hours prior to study entry
* Gestational age \< 37 weeks' gestation at birth
* Nursed in incubator for thermoregulation
* Parents/legal guardians have provided consent for enrollment
Exclusion Criteria
* A neuromuscular condition that affects respiration
* Terminal illness or decision to withhold or limit support
1 Hour
6 Months
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Colm Travers
Principal Investigator
Principal Investigators
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Colm P Travers, MB BCh BAO
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Waldemar A Carlo, MD
Role: STUDY_DIRECTOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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References
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Travers CP, Carlo WA, Nakhmani A, Bhatia S, Gentle SJ, Amperayani VA, Indic P, Aban I, Ambalavanan N. Environmental or Nasal Cannula Supplemental Oxygen for Preterm Infants: A Randomized Cross-Over Trial. J Pediatr. 2018 Sep;200:98-103. doi: 10.1016/j.jpeds.2018.03.010. Epub 2018 Apr 25.
Other Identifiers
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UAB Neo 015
Identifier Type: -
Identifier Source: org_study_id