Recruiting

Observational Study

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT05589831

Conditions

Sleep

Cerebral Oxygenation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Non-invasive Neurally Adjusted Ventilatory Assist

Study Details

Brief 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

Study ID

NCT05589831

Start date

Jul 4, 2023

Status verified date

Mar, 2025

Completion date

Jan, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

  • Number of uninterrupted sleep-wake cycling (SWC) [ Time Frame: For 24 hours after intervention initiation ]

Central Contacts and Locations

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Mar 24, 2025

Last verified

Mar, 2025

Keywords

  • Neurally Adjusted Ventilatory Assist
  • Non-Invasive Positive Pressure Ventilation
  • Preterm Neonates
  • Amplitude integrated electroencephalography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2025-03-24.