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Respiratory Support and Brain Health in Preterm Infants

NCT05589831 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-03-24

No results posted yet for this study

Summary

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

  • Sleep
  • Cerebral Oxygenation

Interventions

DEVICE

Non-invasive Neurally Adjusted Ventilatory Assist

Neurally Adjusted Ventilatory Assist (NAVA) is a new non-invasive ventilation mode that uses the electrical activity of the diaphragm (EAdi) to offer ventilatory assistance in synchrony with patient effort, thus potentially reducing stress and discomfort. It uses electrodes placed on a modified nasogastric feeding tube to detect the electrical activity of the diaphragm (EAdi), such that both the initiation and termination of a breath during each respiratory cycle is in synchrony with the infant's effort

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Poorva Deshpande · MOUNT SINAI HOSPITAL

Eligibility

Min Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-04
Primary Completion
2025-12-31
Completion
2026-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05589831 on ClinicalTrials.gov