Actively Recruiting
Respiratory Support and Brain Health in Preterm Infants: a Prospective Crossover Study
Led by Mount Sinai Hospital, Canada · Updated on 2025-03-24
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Premature infants born before 32 weeks gestation often need breathing support because their lungs are not fully developed. This research compares two non-invasive breathing support methods, Non-Invasive Positive Pressure Ventilation (NIPPV) and Non-invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA), to see how they affect sleep, brain oxygen levels, comfort, and diaphragm function. Researchers aim to find a method that better supports both lung and brain development during this critical period. The study evaluates NIPPV, which provides fixed breaths through a mask or nasal prongs, and NIV-NAVA, which uses a special feeding tube to detect the baby's own breathing efforts and provide synchronized support. Participants are preterm neonates born under 32 weeks gestation who have been stable on either NIPPV or NIV-NAVA for at least 24 hours and are at least 3 days old. Each infant will experience both breathing modes in this prospective crossover study. During the study, researchers will monitor uninterrupted sleep-wake cycles over 24 hours after starting each intervention. They will also assess total quiet sleep time, cerebral oxygen saturation, heart rate variability, and diaphragm function using ultrasound measurements. The study aims to capture detailed physiological data to understand how each ventilation mode impacts the infant's respiratory and brain health during their neonatal intensive care stay.
CONDITIONS
Brief Title
Respiratory Support and Brain Health in Preterm Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Preterm infants born between 22+0 and 31+6 weeks gestational age
- Weigh more than 500 grams at time of consent
- At least 3 days old
- Clinically stable on NIPPV or NIV-NAVA for more than 24 hours, defined by stable oxygen levels, stable pressure settings, no active infection, no low blood pressure, and no use of certain heart or ductus arteriosus medications
You will not qualify if you...
- Grade 3 or 4 intraventricular hemorrhage (severe brain bleeding)
- Birth weight below the 3rd percentile
- Presence of genetic or congenital abnormalities
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At least 48 hours of stable support before study participation; assessments occur over 2 intervention periods of 1 day each
Participants receive respiratory support using two different non-invasive ventilation modes: Nasal Intermittent Positive-Pressure Ventilation (NIPPV) and Non-invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA).
Assessments during 1 day of NIPPV and 1 day of NIV-NAVA
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
Toronto, Ontario, Canada
Actively Recruiting
Research Team
P
Poorva Deshpande
T
Thaiani Wulff
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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