Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study (ECO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794662
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Colm Travers, University of Alabama at Birmingham

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.


Condition or disease Intervention/treatment Phase
Infant, Newborn, Diseases Hypoxia Procedure: Oxygen Environment Procedure: Nasal Cannula Oxygen Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot Study
Study Start Date : April 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Oxygen Environment
Blended oxygen delivered by servo-controlled incubator
Procedure: Oxygen Environment
FiO2 delivered by servo-controlled incubator

Active Comparator: Nasal cannula oxygen
Blended oxygen delivered by nasal cannula
Procedure: Nasal Cannula Oxygen
FiO2 delivered by nasal cannula




Primary Outcome Measures :
  1. 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 Measures :
  1. The proportion of time with oxygen saturations > 95% [ Time Frame: During a 48 hour cross-over period on either intervention ]
  2. The coefficient of variation (relative standard deviation) of oxygen saturations [ Time Frame: During a 48 hour cross-over period on either intervention ]
    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.

  3. The proportion of time spent outside oxygen saturation target ranges (91-95 %) [ Time Frame: During a 48 hour cross-over period on either intervention ]
  4. The proportion of time with oxygen saturations less than 85 % [ Time Frame: During a 48 hour cross-over period on either intervention ]
  5. The effective fraction of inspired oxygen (FiO2) requirement [ Time Frame: During a 48 hour cross-over period on either intervention ]
    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.

  6. 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 ]
    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.

  7. The number of adjustments in FiO2 recorded in the electronic medical record [ Time Frame: During a 48 hour cross-over period on either intervention ]
  8. The number of episodes (≥ 10 seconds) with oxygen saturations less than 80% [ Time Frame: During a 48 hour cross-over period on either intervention ]
  9. The number of recorded episodes of bradycardia <80/min [ Time Frame: During a 48 hour cross-over period on either intervention ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794662


Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Layout table for investigator information
Principal Investigator: Colm P Travers, MB BCh BAO University of Alabama at Birmingham
Study Director: Waldemar A Carlo, MD University of Alabama at Birmingham
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Colm Travers, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02794662    
Other Study ID Numbers: UAB Neo 015
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Colm Travers, University of Alabama at Birmingham:
Oxygen Delivery System, Nasal Cannula
Oxygen Delivery System, Incubator
Additional relevant MeSH terms:
Layout table for MeSH terms
Infant, Newborn, Diseases
Hypoxia
Signs and Symptoms, Respiratory