The goal of this study is to see if a new approach to breathing support ('Pressure Targeted High Flow') is as effective as standard of care ('Continuous Positive Airway Pressure') in prematurely born infants. It will also learn about the effect of these types of breathing support on infant comfort and impact on staffing. The main question it aims to answer is: Does Pressure Targeted High Flow provide enough support in premature infants? Participants will: Take spend 24 hours supported by Pressure Targeted High Flow and 24 hours supported by CPAP. During this time their breathing rate, oxygen requirement and other markers of comfort will be monitored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
High Flow Nasal Cannula therapy with Pressure monitoring to match delivered CPAP pressure
Standard of care CPAP therapy
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
Ascension Seton Medical Center
Austin, Texas, United States
Failure of Support
Failure of respiratory support as defined by increase in fraction of inspired oxygen (FiO2) of ≥0.10, a pH of ≤7.2 with a CO2 ≥60 mm Hg, an increase in transcutaneous CO2 of ≥15mmHg above baseline or ≥2 episodes of apnea requiring positive-pressure ventilation
Time frame: 24 hours
Oxygenation
ratio of mean SpO2 to FiO2
Time frame: 24 hours
Respiratory Rate
Mean respiratory rate
Time frame: 24 hours
Infant comfort - NIPE
Newborn Infant Parasympathetic Evaluation
Time frame: 24 hours
Infant Comfort - Parent
Parental Questionnaire
Time frame: 24 hours
Resource Use
Number of handling/repositioning episodes by nurse/respiratory therapist
Time frame: 24 hours
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