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Respiratory Support and Brain Health in Preterm Infants

Recruitingn/aAges 3 Days - anyAllMount Sinai Hospital, Canada
NCT05589831 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Premature babies often require breathing support during their neonatal intensive care unit stay. This is because their lungs are not fully developed to perform the work of breathing on their own. Although breathing support can be provided via a breathing tube, it is preferable to provide breathing support non-invasively from a breathing machine which is then connected to a mask or prongs placed on the baby's nose. In premature babies born under 32 weeks gestation, a commonly used mode of non-invasive breathing support is called Non-Invasive Positive Pressure Ventilation (NIPPV). In this mode, the breathing machine provides 2 levels of support: one is the constant distending pressure to keep the lungs open and the other provides additional 'breaths' on top of that distending pressure. This is to mimic regular breathing. These breaths are set at a fixed rate and pressure. Although NIPPV pr

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📋 Eligibility rules (as published)
Inclusion Criteria: * Preterm infants born between 22+0 and 31+6 weeks' GA * Weight \> 500 g at the time of approach for consent * A minimum of 3 days of age * Clinically stable for \> 24 hours while receiving NIPPV or NIV-NAVA Clinical stability will be defined as meeting all the following criteria for a 24 hour period prior to recruitment: 1. differences in maximum and minimum fractions of inspired oxygen (FiO2) of \<20% 2. differences in maximum and minimum MAP \<4 cm H2O 3. no active infection 4. no hypotension 5. no use of cardioactive medications or medical therapy for patent ductus arteriosus. Exclusion Criteria: * Infants with IVH of grade 3 or 4 * Birth weight \< 3rd percentile * Genetic or congenital abnormalities
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What it tests

  • Non-invasive Neurally Adjusted Ventilatory Assist
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Where

1 site
Mount Sinai Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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