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

November 30, 2016 updated by: Colm Travers, University of Alabama at Birmingham

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
During a 48 hour cross-over period on either intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of time with oxygen saturations > 95%
Time Frame: During a 48 hour cross-over period on either intervention
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 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.
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
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
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
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.
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
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.
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
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
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
During a 48 hour cross-over period on either intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Colm P Travers, MB BCh BAO, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

June 5, 2016

First Posted (Estimate)

June 9, 2016

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAB Neo 015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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