Actively Recruiting

Age: 3Days +
All Genders
NCT05589831

Respiratory Support and Brain Health in Preterm Infants

Led by Mount Sinai Hospital, Canada · Updated on 2025-03-24

50

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 protects the lungs from injury caused by a breathing tube, the breaths are not in sync with the baby's own breathing effort. Another mode of non-invasive breathing support recently being used in premature infants called Neurally Adjusted Ventilatory Assist (NAVA). When NAVA is provided non-invasively using a mask or prongs similar to NIPPV, it is called Non-invasive NAVA (NIV-NAVA). During NIV-NAVA a special feeding tube is used that detects the baby's own breathing movement from the electrical signal of the baby's diaphragm and feeds back to the machine which then provides a 'top-up' to the baby's own breath. This top-up breath also provides only as much pressure as the baby needs on top on their own breathing effort. Therefore, this is thought to be in sync with the baby's own breathing effort. However, it is not known if this mode of ventilation leads to improved sleep, improved brain oxygen levels, reduced discomfort and improved functioning of the diaphragm. The investigators aim to examine these indices in this research project.

CONDITIONS

Official Title

Respiratory Support and Brain Health in Preterm Infants

Who Can Participate

Age: 3Days +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infants born between 22+0 and 31+6 weeks gestational age
  • Weight greater than 500 grams at the time of consent
  • At least 3 days old
  • Clinically stable for more than 24 hours while receiving NIPPV or NIV-NAVA
  • Clinical stability defined by less than 20% difference in oxygen levels (FiO2) over 24 hours
  • Less than 4 cm H2O difference in mean airway pressure (MAP) over 24 hours
  • No active infection
  • No low blood pressure (hypotension)
  • No use of heart-related medications or treatments for patent ductus arteriosus
Not Eligible

You will not qualify if you...

  • Intraventricular hemorrhage (IVH) grade 3 or 4
  • Birth weight below the 3rd percentile
  • Genetic or congenital abnormalities

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Mount Sinai Hospital

Toronto, Ontario, Canada

Actively Recruiting

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Research Team

P

Poorva Deshpande

CONTACT

T

Thaiani Wulff

CONTACT

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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Respiratory Support and Brain Health in Preterm Infants | DecenTrialz