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

Hypoxia Clinical Trial

— ECO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794662
• Other study ID #: UAB Neo 015
• Status: Completed
• Phase: N/A
• First received: May 10, 2016
• Last updated: November 30, 2016
• Start date: April 2016
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoxia
• Infant, Newborn, Diseases

Intervention

Procedure:
• Oxygen Environment
FiO2 delivered by servo-controlled incubator
• Nasal Cannula Oxygen
FiO2 delivered by nasal cannula

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of episodes with oxygen saturations less than 85% for =10 seconds		During a 48 hour cross-over period on either intervention	Yes
Secondary	The proportion of time with oxygen saturations > 95%		During a 48 hour cross-over period on either intervention	Yes
Secondary	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.	During a 48 hour cross-over period on either intervention	No
Secondary	The proportion of time spent outside oxygen saturation target ranges (91-95 %)		During a 48 hour cross-over period on either intervention	Yes
Secondary	The proportion of time with oxygen saturations less than 85 %		During a 48 hour cross-over period on either intervention	Yes
Secondary	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.	During a 48 hour cross-over period on either intervention	No
Secondary	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.	During a 48 hour cross-over period on either intervention	Yes
Secondary	The number of adjustments in FiO2 recorded in the electronic medical record		During a 48 hour cross-over period on either intervention	No
Secondary	The number of episodes (= 10 seconds) with oxygen saturations less than 80%		During a 48 hour cross-over period on either intervention	Yes
Secondary	The number of recorded episodes of bradycardia <80/min		During a 48 hour cross-over period on either intervention	Yes