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Not yet recruiting NCT07418502

Pressure Targeting During High Flow Therapy in Premature Infants

Phase II Interventional Preterm Infants Respiratory Distress Syndrome (Neonatal) BPD - Bronchopulmonary Dysplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pressure Targeted High Flow, CPAP.
Who it may be relevant to
Registry conditions: Preterm Infants, Respiratory Distress Syndrome (Neonatal), BPD - Bronchopulmonary Dysplasia. Basic parameters: 7 Days — 40 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2 Crossover Trial of Pressure Targeted High Flow Therapy in Premature Infants

Overview

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

  • Procedure Pressure Targeted High Flow
    High Flow Nasal Cannula therapy with Pressure monitoring to match delivered CPAP pressure
  • Procedure CPAP
    Standard of care CPAP therapy

Primary outcome measures

  • Failure of Support [Time frame: 24 hours]
Secondary outcome measures (5)
  • Oxygenation [Time frame: 24 hours]
  • Respiratory Rate [Time frame: 24 hours]
  • Infant comfort - NIPE [Time frame: 24 hours]
  • Infant Comfort - Parent [Time frame: 24 hours]
  • Resource Use [Time frame: 24 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Sharp Mary Birch Hospital for Women & Newborns — San Diego
  • Ascension Seton Medical Center — Austin

Identifiers

NCT: NCT07418502 · FP00010928

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗