Bronchopulmonary dysplasia.
A H Jobe, E Bancalari
https://pubmed.ncbi.nlm.nih.gov/11401896Actively Recruiting
Phase Not Applicable
Age: 23Weeks - 31Weeks
All Genders
ID05908227
Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants (MASTER Trial)
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-02-21
150
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether nasal high flow therapy (NHF) is as effective as the traditional nasal continuous positive airway pressure (NCPAP) for helping stable premature babies breathe. This study focuses on preterm infants with respiratory distress syndrome who require prolonged breathing support. The goal is to compare how well two NHF flow rates perform in maintaining cardiorespiratory stability, while also considering comfort and potential benefits for the infants. The trial randomly assigns preterm infants to one of three groups: NHF at 8L/min, NHF at 6L/min, or NCPAP at 6 cm H2O. All infants are stable on NCPAP before randomization. The study takes place at two neonatal centers and monitors infants during the intervention and follow-up periods, which may last from 7 days up to about 10 weeks. Researchers assess breathing support effectiveness and comfort using various clinical measures and scoring systems. During the trial, babies are closely monitored for treatment failure within 24 hours and other vital signs such as apnea episodes, heart rate, oxygen levels, and respiratory rate. Comfort assessments, cerebral oxygen saturation, lung function, and growth measurements are also collected. Parental observations of comfort and bonding are evaluated. The study tracks outcomes until discharge, estimated around 38 to 40 weeks postmenstrual age, ensuring thorough safety and effectiveness monitoring throughout the participation period.
CONDITIONS
Brief Title
Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants
Who Can Participate
Age: 23Weeks - 31Weeks
All Genders
Eligibility Criteria
You may qualify if you...
- Preterm infants up to 31 weeks and 6 days gestational age admitted to specified neonatal units
- Older than 2 days of life
- Stable on nasal continuous positive airway pressure (NCPAP) at 6 cm H2O for at least 24 hours
- Fewer than or equal to 2 apneas with bradycardia per hour in the last 6 hours
- Fraction of inspired oxygen (FiO2) less than or equal to 0.3 and not increasing
- No significant chest retractions (Silverman Score less than 5)
- Respiratory rate less than or equal to 60 breaths per minute
- No need for intermittent positive pressure ventilation
- Parents or legal guardians aged 18 years or older
- Written informed consent from parents or legal representatives
You will not qualify if you...
- Significant fetal anomalies
- Receiving primary palliative care
- Stable on NCPAP at 6 cm H2O according to stability criteria for more than 120 hours
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Between 7 days to 10 weeks
Participants receive nasal high flow therapy at either 8L/min or 6L/min, or nasal continuous positive airway pressure at 6 cm H2O to support breathing.
Daily assessments during treatment
Follow-up
Duration - Up to approximately 38 to 40 weeks postmenstrual age
Participants are monitored for long-term respiratory and developmental outcomes until approximately 38 to 40 weeks postmenstrual age.
Periodic visits depending on clinical status
Trial Site Locations
Total: 2 locations
1
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
2
Department of Pediatrics, Inselspital
Bern, Switzerland, 3010
Actively Recruiting
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Research Team
L
Lisa Marie Bünte
A
André Kidszun, Prof. Dr. med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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