Work of Breathing During Non-invasive Ventilation in Premature Neonates

Completed · Not applicable

Conditions studied: Respiratory Distress Syndrome, Newborn, Bronchopulmonary Dysplasia

In brief

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.

Key facts

Study ID

NCT02788110

Run by

Arkansas Children's Hospital Research Institute

People needed

15

Starts

2016-08-01

Expected to finish

2018-06-01

Last updated by the study team

2019-01-11

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age at birth between 24 and 34 weeks
• Receiving noninvasive ventilation
• Between 1 and 2 kg current weight
• Current FiO2 requirement less than 0.40
• Clinical stability

You may not qualify if…

• Known major congenital anomalies (congenital heart disease, abdominal wall defects, gastrointestinal tract defects, cleft palate, or neurologic defects)
• Clinical instability (temperature instability, heart failure, bleeding, active infection, significant apnea or bradycardia)
• Known cystic fibrosis
• Use of inhaled nitric oxide
• Cyanotic congenital heart disease

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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