Respiratory Support and Brain Health in Preterm Infants

NCT05589831 | Recruiting

• 1 other identifier: 22-0128-A
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of uninterrupted sleep-wake cycling (SWC)

  An uninterrupted SWC will be defined as a smooth and gradual decrease in the minimum amplitude on aEEG to quiet sleep (QS), followed by a gradual increase to active sleep or awake state (AS). An interrupted SWC will be defined as a sudden or sharp increase in the minimum amplitude during QS with change to AS state that may or may not be followed by a further drop in QS.

  For 24 hours after intervention initiation

Secondary Outcomes (7)

• Total duration of quiet sleep (QS)

  For 24 hours after intervention initiation

• Cerebral oxygen saturation (CrSO2)

  For 24 hours after intervention initiation

• Newborn Infant Parasympathetic Evaluation (NIPE) index

  For 24 hours after intervention initiation

• Diaphragmatic thickness

  1 day during Nasal Intermittent Positive-Pressure Ventilation (NIPPV) period and 1 day during the Non-Invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA) period

• Diaphragm thickness fraction

  1 day during Nasal Intermittent Positive-Pressure Ventilation (NIPPV) period and 1 day during the Non-Invasive Neurally Adjusted Ventilatory Assist (NIV-NAVA) period

Interventions

Non-invasive Neurally Adjusted Ventilatory Assist DEVICE

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

Also known as: NIV-NAVA

Eligibility Criteria

• Age: 3 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants at tertiary NICU at Mount Sinai Hospital (Toronto, Ontario).

You may qualify if:

• 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:
• differences in maximum and minimum fractions of inspired oxygen (FiO2) of \<20%
• differences in maximum and minimum MAP \<4 cm H2O
• no active infection
• no hypotension
• no use of cardioactive medications or medical therapy for patent ductus arteriosus.

You may not qualify if:

• Infants with IVH of grade 3 or 4
• Birth weight \< 3rd percentile
• Genetic or congenital abnormalities

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, Canada

RECRUITING

Study Officials

• Poorva Deshpande

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Poorva Deshpande

CONTACT

416-586-4800; poorva.deshpande@sinaihealth.ca

Thaiani Wulff

CONTACT

416-586-4800; thaiani.wulff@sinaihealth.ca

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 21, 2022
• Study Start: July 4, 2023
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)