Nasal Noninvasive NAVA in the Very Low Birth Weight Infant
The purpose of this study is to determine if a new type of mechanical ventilation, or breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide additional support to infants who were born prematurely. Investigators are looking to determine if in two hours infants who weighed less than 1500 grams or 3 pounds 5 ounces, will demonstrate a decrease in the amount of carbon dioxide (the gas that humans exhale) dissolved in their blood as compared to prior to starting the study. This will be accomplished by enrolling infants who are stable on their current type of mechanical breathing that provides a constant air flow into the infant. This type of mechanical support helps keep the lungs inflated but does not help remove carbon dioxide. This study will change the type of mechanical support to a type of support called neurally adjusted ventilatory assist or NAVA. This type of mechanical support detects when the infant is breathing in by having electrical sensors on a feeding tube that is placed into the stomach through the nose or mouth. These electrical sensors detect when the diaphragm or the muscle that helps humans breath is trying to take a breath in. When the NAVA ventilator senses the attempt to breath, it provides additional air flow to make the effort of breathing easier. The ventilator will be attached to a tube or cannula that is placed into the infant's nose. After two hours of being on the NAVA ventilator a repeat measure of carbon dioxide in the blood will be performed by taking a small amount of blood from the infant's heel.
Inadequate; Pulmonary Ventilation, Newborn
Infant, Very Low Birth Weight
Procedure: Nasal NIV-NAVA
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Nasal Noninvasive NAVA Provides Ventilation in the Very Low Birth Weight Infant|
- Decrease in partial pressure of carbon dioxide on capillary blood gas [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
- Decrease in fraction of inspired oxygen [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: Nasal NIV-NAVA
Infants will be transitioned from their current mode of ventilation to nasal NIV-NAVA. If patients are currently on nasal NIV-NAVA an increase in the NAVA level will be utilized for the intervention.
Procedure: Nasal NIV-NAVA
Infants will be placed on nasal NIV-NAVA. Patients initial NAVA level will be set to generate a peak inspiratory pressure that is 8 cm of water greater than their current peak end expiratory pressure. If the infants are on nasal NIV-NAVA at the time of study entry their NAVA level will be increased by 50% rounded up to the nearest 0.1 cm of water per microvolt.
|Contact: Gary J Kummet, M.D.||firstname.lastname@example.org|
|Contact: Tarah T. Colaizy, M.D., MPHemail@example.com|
|Principal Investigator:||Tarah T Colaizy, M.D., MPH||University of Iowa|
|Study Director:||Gary J Kummet, M.D.||University of Iowa|
|Study Director:||Jonathan C Klein, M.D.||University of Iowa|