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Nasal Noninvasive NAVA in the Very Low Birth Weight Infant

NCT01785563 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-06-09

Study results available
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Summary

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.

Conditions

  • Inadequate; Pulmonary Ventilation, Newborn
  • Infant, Very Low Birth Weight

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Tarah T Colaizy

    lead OTHER

Principal Investigators

  • Tarah T Colaizy, M.D., MPH · University of Iowa

  • Gary J Kummet, M.D. · University of Iowa

  • Jonathan C Klein, M.D. · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Days
Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2018-12-31
Completion
2018-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01785563 on ClinicalTrials.gov