Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study (ECO)
Primary Purpose
Infant, Newborn, Diseases, Hypoxia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxygen Environment
Nasal Cannula Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Infant, Newborn, Diseases focused on measuring Oxygen Delivery System, Nasal Cannula, Oxygen Delivery System, Incubator
Eligibility Criteria
Inclusion Criteria:
- Infant requiring supplemental oxygen therapy via oxygen environment (OE) or nasal cannula (NC) with flow rates ≤ 1.0 liter per kilogram per minute
- 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 major malformation
- A neuromuscular condition that affects respiration
- Terminal illness or decision to withhold or limit support
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Oxygen Environment
Nasal cannula oxygen
Arm Description
Blended oxygen delivered by servo-controlled incubator
Blended oxygen delivered by nasal cannula
Outcomes
Primary Outcome Measures
The number of episodes with oxygen saturations less than 85% for ≥10 seconds
Secondary Outcome Measures
The proportion of time with oxygen saturations > 95%
The coefficient of variation (relative standard deviation) of oxygen saturations
The coefficient of variation is a standardized measure of dispersion of a frequency distribution defined as the ratio of the standard deviation to the mean. It will be used in this study to assess the stability of oxygen saturations.
The proportion of time spent outside oxygen saturation target ranges (91-95 %)
The proportion of time with oxygen saturations less than 85 %
The effective fraction of inspired oxygen (FiO2) requirement
Effective FiO2 requirement is the actual fraction of inspired oxygen measured at the hypopharynx. In this study we will use tables based on studies where this has been previously calculated to determine the effective FiO2 requirement on the different modes of oxygen therapy during the study period.
The number of recorded interventions with tactile stimulation/blow by oxygen/CPAP/IPPV
Each intervention recorded in the electronic medical record will count as 1 intervention regardless of which intervention is recorded. Therefore the same unit of measurement will be used to assess each measure.
The number of adjustments in FiO2 recorded in the electronic medical record
The number of episodes (≥ 10 seconds) with oxygen saturations less than 80%
The number of recorded episodes of bradycardia <80/min
Full Information
NCT ID
NCT02794662
First Posted
May 10, 2016
Last Updated
November 30, 2016
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT02794662
Brief Title
Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study
Acronym
ECO
Official Title
Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Newborn, Diseases, Hypoxia
Keywords
Oxygen Delivery System, Nasal Cannula, Oxygen Delivery System, Incubator
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxygen Environment
Arm Type
Experimental
Arm Description
Blended oxygen delivered by servo-controlled incubator
Arm Title
Nasal cannula oxygen
Arm Type
Active Comparator
Arm Description
Blended oxygen delivered by nasal cannula
Intervention Type
Procedure
Intervention Name(s)
Oxygen Environment
Intervention Description
FiO2 delivered by servo-controlled incubator
Intervention Type
Procedure
Intervention Name(s)
Nasal Cannula Oxygen
Intervention Description
FiO2 delivered by nasal cannula
Primary Outcome Measure Information:
Title
The number of episodes with oxygen saturations less than 85% for ≥10 seconds
Time Frame
During a 48 hour cross-over period on either intervention
Secondary Outcome Measure Information:
Title
The proportion of time with oxygen saturations > 95%
Time Frame
During a 48 hour cross-over period on either intervention
Title
The coefficient of variation (relative standard deviation) of oxygen saturations
Description
The coefficient of variation is a standardized measure of dispersion of a frequency distribution defined as the ratio of the standard deviation to the mean. It will be used in this study to assess the stability of oxygen saturations.
Time Frame
During a 48 hour cross-over period on either intervention
Title
The proportion of time spent outside oxygen saturation target ranges (91-95 %)
Time Frame
During a 48 hour cross-over period on either intervention
Title
The proportion of time with oxygen saturations less than 85 %
Time Frame
During a 48 hour cross-over period on either intervention
Title
The effective fraction of inspired oxygen (FiO2) requirement
Description
Effective FiO2 requirement is the actual fraction of inspired oxygen measured at the hypopharynx. In this study we will use tables based on studies where this has been previously calculated to determine the effective FiO2 requirement on the different modes of oxygen therapy during the study period.
Time Frame
During a 48 hour cross-over period on either intervention
Title
The number of recorded interventions with tactile stimulation/blow by oxygen/CPAP/IPPV
Description
Each intervention recorded in the electronic medical record will count as 1 intervention regardless of which intervention is recorded. Therefore the same unit of measurement will be used to assess each measure.
Time Frame
During a 48 hour cross-over period on either intervention
Title
The number of adjustments in FiO2 recorded in the electronic medical record
Time Frame
During a 48 hour cross-over period on either intervention
Title
The number of episodes (≥ 10 seconds) with oxygen saturations less than 80%
Time Frame
During a 48 hour cross-over period on either intervention
Title
The number of recorded episodes of bradycardia <80/min
Time Frame
During a 48 hour cross-over period on either intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infant requiring supplemental oxygen therapy via oxygen environment (OE) or nasal cannula (NC) with flow rates ≤ 1.0 liter per kilogram per minute
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 major malformation
A neuromuscular condition that affects respiration
Terminal illness or decision to withhold or limit support
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colm P Travers, MB BCh BAO
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Waldemar A Carlo, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29705116
Citation
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.
Results Reference
derived
Learn more about this trial
Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study
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