Infant, Newborn, DiseasesECONCT02794662
Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study
A study testing Oxygen Environment and Nasal Cannula Oxygen in people with Infant, Newborn, Diseases and Hypoxia, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 hour to 6 months
- Conditions the study is for
- Infant, Newborn, Diseases, Hypoxia
- What is being tested?
- Oxygen Environment and Nasal Cannula Oxygen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- A major malformation
- A neuromuscular condition that affects respiration
- Terminal illness or decision to withhold or limit support
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this 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.
Read the 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.
- Conditions
- Infant, Newborn, Diseases, Hypoxia
- Being tested
- Oxygen Environment, Nasal Cannula Oxygen
- Keywords
- Oxygen Delivery System, Nasal Cannula, Oxygen Delivery System, Incubator
- Medical subject headings
- Infant, Newborn, Diseases, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen EnvironmentProcedure or surgery
FiO2 delivered by servo-controlled incubator
Nasal Cannula OxygenProcedure or surgery
FiO2 delivered by nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| Oxygen Environment | Experimental | Blended oxygen delivered by servo-controlled incubator Receives: Procedure: Oxygen Environment |
| Nasal cannula oxygen | Active comparator | Blended oxygen delivered by nasal cannula Receives: Procedure: Nasal Cannula Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of episodes with oxygen saturations less than 85% for ≥10 seconds
Measured: During a 48 hour cross-over period on either intervention
Secondary outcomes (9)
The proportion of time with oxygen saturations > 95%
Measured: During a 48 hour cross-over period on either intervention
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.
Measured: During a 48 hour cross-over period on either intervention
The proportion of time spent outside oxygen saturation target ranges (91-95 %)
Measured: During a 48 hour cross-over period on either intervention
The proportion of time with oxygen saturations less than 85 %
Measured: During a 48 hour cross-over period on either intervention
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.
Measured: During a 48 hour cross-over period on either intervention
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.
Measured: During a 48 hour cross-over period on either intervention
The number of adjustments in FiO2 recorded in the electronic medical record
Measured: During a 48 hour cross-over period on either intervention
The number of episodes (≥ 10 seconds) with oxygen saturations less than 80%
Measured: During a 48 hour cross-over period on either intervention
The number of recorded episodes of bradycardia <80/min
Measured: During a 48 hour cross-over period on either intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant, Newborn, DiseasesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colm Travers, University of Alabama at Birmingham
- Investigators
- Colm P Travers, MB BCh BAO, Principal investigator, University of Alabama at BirminghamWaldemar A Carlo, MD, Study director, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794662
- Sponsor's protocol ID
- UAB Neo 015
- Acronym
- ECO
- Status last verified
- Nov 2016
- First submitted
- 10 May 2016
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29705116
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study
- ClinicalTrials.gov ID
- NCT02794662
- Acronym / sponsor ID
- ECO / UAB Neo 015
- Conditions
- Infant, Newborn, Diseases, Hypoxia
- Keywords
- Oxygen Delivery System, Nasal Cannula, Oxygen Delivery System, Incubator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen Environment | Experimental | Procedure: Oxygen EnvironmentBlended oxygen delivered by servo-controlled incubator |
| Nasal cannula oxygen | Active comparator | Procedure: Nasal Cannula OxygenBlended oxygen delivered by nasal cannula |
Who may qualify
- Ages
- 1 hour to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- A major malformation
- A neuromuscular condition that affects respiration
- Terminal illness or decision to withhold or limit support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen EnvironmentFiO2 delivered by servo-controlled incubator | Procedure or surgery | Oxygen Environment |
| Nasal Cannula OxygenFiO2 delivered by nasal cannula | Procedure or surgery | Nasal cannula oxygen |
Primary outcome
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
9 secondary outcomes
The proportion of time with oxygen saturations > 95%
Time frame: During a 48 hour cross-over period on either intervention
The coefficient of variation (relative standard deviation) of oxygen saturations
Time frame: During a 48 hour cross-over period on either intervention
The proportion of time spent outside oxygen saturation target ranges (91-95 %)
Time frame: During a 48 hour cross-over period on either intervention
The proportion of time with oxygen saturations less than 85 %
Time frame: During a 48 hour cross-over period on either intervention
The effective fraction of inspired oxygen (FiO2) requirement
Time frame: During a 48 hour cross-over period on either intervention
The number of recorded interventions with tactile stimulation/blow by oxygen/CPAP/IPPV
Time frame: During a 48 hour cross-over period on either intervention
The number of adjustments in FiO2 recorded in the electronic medical record
Time frame: During a 48 hour cross-over period on either intervention
The number of episodes (≥ 10 seconds) with oxygen saturations less than 80%
Time frame: During a 48 hour cross-over period on either intervention
The number of recorded episodes of bradycardia <80/min
Time frame: During a 48 hour cross-over period on either intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Derived from this study: PubMed 29705116Travers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colm P Travers, MB BCh BAO principal investigator
University of Alabama at Birmingham
Waldemar A Carlo, MD study director
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen Environment and Nasal Cannula Oxygen in people with Infant, Newborn, Diseases and Hypoxia, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.