Nasal Noninvasive NAVA in the Very Low Birth Weight Infant

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by University of Iowa
Sponsor:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01785563
First received: February 1, 2013
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Inadequate; Pulmonary Ventilation, Newborn
Infant, Very Low Birth Weight
Procedure: Nasal NIV-NAVA

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Decrease in partial pressure of carbon dioxide on capillary blood gas [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease in fraction of inspired oxygen [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
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)
Arms Assigned Interventions
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.
Other Names:
  • noninvasive
  • neurally adjusted ventilatory assist
  • nasal pharyngeal

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • birth weight less than 1,500 grams
  • Clinical history of respiratory distress syndrome treated with surfactant
  • Chronological age greater than or equal to seven days
  • 48 hours post-extubation or greater
  • Medically stable per primary medical team
  • Receiving ventilatory support on one of the following systems via nasal pharyngeal tube or nasal prongs:continuous positive airway pressure (CPAP), intermittent mechanical ventilation (IMV), or neutrally adjusted ventilatory assistance (NAVA)
  • Receiving ventilatory support via high flow nasal cannula if the flow is large enough to provide a positive end expiratory pressure (PEEP) of 6 as defined by PEEP of 6 = 0.68 * weight (kg) + 0.92
  • Capillary blood gas via heel stick within 24 hours that demonstrates a pH of less than or equal to 7.35 and/or a partial pressure of carbon dioxide (pCO2) greater than or equal to 45 mmHg

Exclusion criteria:

  • Severe congenital abnormalities
  • Grade III or IV interventricular hemorrhage.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785563

Contacts
Contact: Gary J Kummet, M.D. 319-356-7096 gary-kummet@uiowa.edu
Contact: Tarah T. Colaizy, M.D., MPH 319-356-3508 tarah-colaizy@uiowa.edu

Sponsors and Collaborators
University of Iowa
Investigators
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
  More Information

Publications:

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT01785563     History of Changes
Other Study ID Numbers: Nasal NIV-NAVA
Study First Received: February 1, 2013
Last Updated: February 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
NAVA
NIV-NAVA
VLBW
electrical activity of the diaphragm
neural trigger, mechanical ventilation
respiratory distress syndrome

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 01, 2014