BPD - Bronchopulmonary Dysplasia, Preterm Infants, Respiratory Distress Syndrome (Neonatal)
Conditions
Keywords
preterm, CPAP, High Flow
Brief summary
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.
Interventions
PROCEDUREPressure Targeted High Flow
High Flow Nasal Cannula therapy with Pressure monitoring to match delivered CPAP pressure
PROCEDURECPAP
Standard of care CPAP therapy
Sponsors
University of Texas at Austin
Sharp Mary Birch Hospital for Women & Newborns
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Days to 40 Weeks
Healthy volunteers
No
Inclusion criteria
* 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 * Requiring an FiO2 of ≤0.60
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure of Support | 24 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygenation | 24 hours | ratio of mean SpO2 to FiO2 |
| Respiratory Rate | 24 hours | Mean respiratory rate |
| Infant comfort - NIPE | 24 hours | Newborn Infant Parasympathetic Evaluation |
| Infant Comfort - Parent | 24 hours | Parental Questionnaire |
| Resource Use | 24 hours | Number of handling/repositioning episodes by nurse/respiratory therapist |
Countries
United States
Contacts
CONTACTAlan Groves
Outcome results
None listed