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Nasal Noninvasive NAVA in the Very Low Birth Weight Infant

Sponsor
Tarah T Colaizy (Other)
Overall Status
Completed
CT.gov ID
NCT01785563
Collaborator
(none)
40
Enrollment
2
Locations
1
Arm
70.9
Duration (Months)
20
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Nasal NIV-NAVA
 N/A

Detailed Description

Baseline Data Collection:

Demographic data: Patient gestational age at delivery, maternal betamethasone therapy, APGAR scores, admission weight, receipt of surfactant administered, age at extubation, time since extubation, current post menstrual age, and current weight.

Baseline vitals and ventilation mode: Heart rate, blood pressure, FiO2 (fraction of inspired oxygen), oxygen saturations, transcutaneous partial pressure of carbon dioxide (TCO2) and current mode of ventilation will be recorded four times in a one minute period and the values average to minimize normal variation. Intervention time will be manipulated to begin no later than one hour after the previous feeding, as to minimize interruption of feedings to no greater than 30 minutes.

Safety Safety: TCO2 monitor will be attached to the infant and the device will be calibrated according to protocol (reference TCO2 monitor manual). Carbon dioxide diffusion through the skin will be monitored continuously during the intervention (Bromley 08) to avoid periods of hypo or hypercarbia.

Edi (electrical activity of the diaphragm) Catheter placement: Edi catheter size will be selected according to infant's weight and length. It will be inserted according to manufacturer's guidelines and adjustments will be made to optimize positioning (reference NAVA manual).

NAVA settings:

Infants will be maintained on previous level of PEEP (positive end expiratory pressure) or calculated PEEP, rounding up to whole numbers. Initial NAVA level will be determined by starting with an initial NAVA level of 0.5 microvolts/cm of H20. The NAVA level will then be adjusted either by increasing or decreasing to generate a PIP that is a minimum of 8 cm of H2O greater than the current PEEP. Apnea alarm will be set at 5 seconds, which will initiate the NAVA back up setting if no electrical activity is detected by the Edi catheter. Back up NAVA settings will be set with a PIP of 12 cm of H20 greater than current PEEP, respiratory rate of 60 breaths per minute (RR) and inspiratory time of 0.5 seconds. Fraction of inspired oxygen (FiO2) will be adjusted to keep infant's oxygen saturations within previously established clinical parameters.

Study Intervention Procedure and Data Collection:

At initiation of intervention, and at time 30, 60, 90, and 120 minutes, heart rate (HR), respiratory rate (RR), tidal volume (TV), minute ventilation, FiO2, oxygen saturations, peak Edi and PIP will be recorded four times in a one minute period and the values average to minimize normal variation. Current NAVA settings, TCO2, and blood pressure (BP) will also be recorded. At 60 minutes of intervention if the TCO2 level has not decreased by 5 torr from baseline or has risen, the current NAVA level will be increased by 50%. At 90 minutes if the TCO2 level has not decreased by 5 torr from baseline or has risen; the NAVA level will be increased by 50% from the current level. At the completion of the study (120 minutes or pCO2 outside of established limits) the HR, RR, BP, TV, minute ventilation, FiO2, oxygen saturations, peak Edi and PIP will be recorded four times in a one minute period and the values average to minimize normal variation. A capillary blood gas will be obtained according to standard unit protocol with a warmed heel.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Nasal Noninvasive NAVA Provides Ventilation in the Very Low Birth Weight Infant
Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

Arm Intervention/Treatment
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.

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.
Other Names:
  • noninvasive
  • neurally adjusted ventilatory assist
  • nasal pharyngeal

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Partial Pressure of Carbon Dioxide on Capillary Blood Gas [2 hours]

      difference between pCO2 (mm Hg) on capillary blood gas obtained within 6 hours of study and immediately after 2 hour study period

    Secondary Outcome Measures

    1. Change in Fraction of Inspired Oxygen [2 hours]

      difference between fiO2 at start of study and that at the last measurement timepoint at 120 minutes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Days to 1 Year
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Iowa NICU Iowa City Iowa United States 52242
    2 University of Iowa Iowa City Iowa United States 52242

    Sponsors and Collaborators

    • Tarah T Colaizy

    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

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Tarah T Colaizy, Principal Investigator, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT01785563
    Other Study ID Numbers:
    • 201208771
    First Posted:
    Feb 7, 2013
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Tarah T Colaizy, Principal Investigator, University of Iowa
    NAVA
    NIV-NAVA
    VLBW
    electrical activity of the diaphragm
    neural trigger, mechanical ventilation
    respiratory distress syndrome
    Additional relevant MeSH terms:
    Body Weight
    Birth Weight

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Nasal Non-Invasive NAVA Group
    Arm/Group Description Infants < 1500g birthweight, who were intubated and received surfactant at birth, at least 7 days old, and at least 48 hours after endotracheal extubation. Infants must be receiving respiratory support at study entry, including CPAP or non-invasive mechanical ventilation.
    Period Title: Overall Study
    STARTED 40
    COMPLETED 27
    NOT COMPLETED 13

    Baseline Characteristics

    Arm/Group Title Nasal Non-Invasive NAVA Group
    Arm/Group Description Infants < 1500g birthweight, who were intubated and received surfactant at birth, at least 7 days old, and at least 48 hours after endotracheal extubation. Infants must be receiving respiratory support at study entry, including CPAP or non-invasive mechanical ventilation.
    Overall Participants 27
    Age (Count of Participants)
    <=18 years
    27
    100%
    Between 18 and 65 years
    0
    0%
    >=65 years
    0
    0%
    Age (days) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [days]
    47
    (29)
    Sex: Female, Male (Count of Participants)
    Female
    12
    44.4%
    Male
    15
    55.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    1
    3.7%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    4
    14.8%
    White
    19
    70.4%
    More than one race
    3
    11.1%
    Unknown or Not Reported
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    27
    100%
    screening capillary blood gas pH (ph units) [Mean (Full Range) ]
    Mean (Full Range) [ph units]
    7.38

    Outcome Measures

    1. Primary Outcome
    Title Change in Partial Pressure of Carbon Dioxide on Capillary Blood Gas
    Description difference between pCO2 (mm Hg) on capillary blood gas obtained within 6 hours of study and immediately after 2 hour study period
    Time Frame 2 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Nasal Non-Invasive NAVA Group
    Arm/Group Description Infants < 1500g birthweight, who were intubated and received surfactant at birth, at least 7 days old, and at least 48 hours after endotracheal extubation. Infants must be receiving respiratory support at study entry, including CPAP or non-invasive mechanical ventilation.
    Measure Participants 27
    Mean (Standard Deviation) [mm Hg]
    0.019
    (0.037)
    2. Secondary Outcome
    Title Change in Fraction of Inspired Oxygen
    Description difference between fiO2 at start of study and that at the last measurement timepoint at 120 minutes
    Time Frame 2 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Nasal Non-Invasive NAVA Group
    Arm/Group Description Infants < 1500g birthweight, who were intubated and received surfactant at birth, at least 7 days old, and at least 48 hours after endotracheal extubation. Infants must be receiving respiratory support at study entry, including CPAP or non-invasive mechanical ventilation.
    Measure Participants 27
    Mean (Standard Deviation) [percentage of oxygen in inspired gas]
    -0.012
    (0.0463)

    Adverse Events

    Time Frame Each subject was monitored for adverse events potentially attributable to the study intervention from the time of enrollment and completion of the study until their discharge from the hospital, which varied from 3 weeks to 3 months.
    Adverse Event Reporting Description
    Arm/Group Title Nasal Non-Invasive NAVA Group
    Arm/Group Description Infants < 1500g birthweight, who were intubated and received surfactant at birth, at least 7 days old, and at least 48 hours after endotracheal extubation. Infants must be receiving respiratory support at study entry, including CPAP or non-invasive mechanical ventilation.
    All Cause Mortality
    Nasal Non-Invasive NAVA Group
    Affected / at Risk (%) # Events
    Total 0/27 (0%)
    Serious Adverse Events
    Nasal Non-Invasive NAVA Group
    Affected / at Risk (%) # Events
    Total 0/27 (0%)
    Other (Not Including Serious) Adverse Events
    Nasal Non-Invasive NAVA Group
    Affected / at Risk (%) # Events
    Total 0/27 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Tarah T. Colaizy
    Organization University of Iowa
    Phone 3193255640
    Email tarah-colaizy@uiowa.edu
    Responsible Party:
    Tarah T Colaizy, Principal Investigator, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT01785563
    Other Study ID Numbers:
    • 201208771
    First Posted:
    Feb 7, 2013
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    May 1, 2022