Work of Breathing During Non-invasive Ventilation in Premature Neonates

Summary

Background:

Non-invasive forms of respiratory support have been developed to manage respiratory distress and failure in premature newborns without exposing them to the risks associated with invasive mechanical ventilation. It has been difficult to synchronize non-invasive ventilation due to the large air leaks, high respiratory rates, and small tidal volumes inherent to this interface and population. Neurally adjusted ventilatory assist (NAVA) is a novel mode of ventilation that uses a functional naso/orogastric tube with embedded electrodes which detect diaphragmatic contractions (called the Edi signal). NAVA uses this Edi signal to synchronize ventilator support to the patient's own respiratory efforts and to support these efforts as needed. Few studies have examined the use of NAVA with non-invasive ventilation (NIV) in preterm neonates. A group at Arkansas Children's Hospital recently completed a study, looking at work of breathing in an animal model comparing NIV NAVA with the unsynchronized nasal intermittent positive pressure (NIPPV) mode currently used at this hospital. They were able to show that work of breathing was lower with NAVA in this model. This study will take what was shown in the animal model and translate this to the bedside. Using respiratory inductance plethysmography to measure thoracoabdominal asynchrony, this study will compare work of breathing during NIPPV versus NIV NAVA in preterm neonates with respiratory insufficiency.

Hypothesis:

Work of breathing as estimated by the phase angle (θ) using respiratory inductance plethysmography will be decreased with the use of NIV NAVA in comparison to unsynchronized NIPPV in premature neonates with respiratory insufficiency.

Methods:

Fifteen premature neonates of between 1-2 kilograms' current weight, with gestational age at birth between 24-34 weeks, and receiving non-invasive ventilation will be enrolled in the study after consent is obtained. The infants will be ventilated using NIV NAVA and NIPPV applied in random order for 15 minutes each while using respiratory inductance plethysmography to measure thoracoabdominal asynchrony as an estimate of work of breathing.

Significance:

This study will identify whether or not NIV NAVA has advantages over NIPPV for improving work of breathing in premature neonates.

Conditions

• Respiratory Distress Syndrome, Newborn
• Bronchopulmonary Dysplasia

Interventions

OTHER

Noninvasive neurally adjusted ventilatory assist (NIV NAVA)

Neurally adjusted ventilatory assist (NAVA) is a mode of ventilation that uses a functional naso/orogastric tube with embedded electrodes which detect diaphragmatic contractions (called the Edi signal). NAVA uses this Edi signal to synchronize ventilator support to the patient's own respiratory efforts and to support these efforts as needed.

OTHER

Nasal intermittent positive pressure ventilation (NIPPV)

Nasal intermittent positive pressure ventilation (NIPPV) or noninvasive pressure control ventilation (NIV PC) is a mode of ventilation delivering unsynchronized puffs of air or "breaths" to a baby through nasal cannulae.

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute

  lead OTHER

Principal Investigators

• David N Matlock, MD · University of Arkansas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Max Age

12 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2018-06-30

Completion

2018-06-30

Countries

• United States

Study Locations