Pressure Targeting During High Flow Therapy in Premature Infants
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age7-40
SponsorUniversity of Texas at Austin
About this trial
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.
Eligibility criteria
Qualifiers
Delivery at >24+0 weeks and ≤32+6 weeks of gestation
Postnatal age >7 days but < 6 weeks old
Weight ≥1,000grams at the time of study
Receiving clinically prescribed CPAP at pressures of 5-8cm H2O
Disqualifiers
Chromosomal disorder (aneuploidy)
Presence of major congenital birth defect including airway anomalies, congenital diaphragmatic hernia or cardiac defects (other than patent foramen ovale and patent ductus arteriosus)
Prior pneumothorax
Infants in whom chance of survival is uncertain
Trial design
Treatments tested in this trial
- Pressure Targeted High Flow
- CPAP
Treatment groups
78 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Texas at Austin
Lead sponsor
Sharp Mary Birch Hospital for Women & Newborns
Collaborator
Source ClinicalTrials.gov