Hypoxia Clinical Trial
— ECOOfficial title:
Environmental or Nasal Cannula Oxygen for Preterm Infants Receiving Oxygen Therapy: a Randomized Cross-over Pilot 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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
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 |
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