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Pressure Targeting During High Flow Therapy in Premature Infants

ConditionsPreterm InfantsRespiratory Distress Syndrome (Neonatal)BPD - Bronchopulmonary Dysplasia
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Pressure Targeted High Flow

    Procedure/Surgery

    High Flow Nasal Cannula therapy with Pressure monitoring to match delivered CPAP pressure

  • CPAP

    Procedure/Surgery

    Standard of care CPAP therapy

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: PTHF FirstOther 1 intervention
Group B: CPAP FirstOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Oxygenation

ratio of mean SpO2 to FiO2

Time frame
24 hours
2

Respiratory Rate

Mean respiratory rate

Time frame
24 hours
3

Infant comfort - NIPE

Newborn Infant Parasympathetic Evaluation

Time frame
24 hours
4

Infant Comfort - Parent

Parental Questionnaire

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas at Austin

Lead sponsor

Sharp Mary Birch Hospital for Women & Newborns

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: