<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03242057</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201701971</org_study_id>
    <nct_id>NCT03242057</nct_id>
  </id_info>
  <brief_title>Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA</brief_title>
  <official_title>Comparison of Primary Extubation Failure Between Non-invasive Positive Pressure Ventilation (NIPPV) and Non Invasive Neural Access Ventilatory Assist (NI-NAVA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Extubation failure is a significant problem in preterm neonates and prolonged intubation is a&#xD;
      well-documented risk factor for development of chronic lung disease. Out of the respiratory&#xD;
      modalities available to extubate a preterm neonate; high flow nasal canula, nasal continuous&#xD;
      positive airway pressure (nCPAP) and noninvasive positive pressure ventilation (NIPPV) are&#xD;
      the most commonly used.&#xD;
&#xD;
      A recent Cochrane meta-analysis concluded that NIPPV has lower extubation failure as compared&#xD;
      to nCPAP (30% vs. 40%)&#xD;
&#xD;
      NAVA (neurally adjusted ventilatory assist), a relatively new mode of mechanical ventilation&#xD;
      in which the diaphragmatic electrical activity initiates a ventilator breath and adjustment&#xD;
      of a preset gain (NAVA level) determines the peak inspiratory pressure. It has been reported&#xD;
      to improve patient - ventilator synchrony and minimize mean airway pressure and ability to&#xD;
      wean an infant from a ventilator. However till date there has been no head to head comparison&#xD;
      of extubation failure in infants managed on NAVA with conventional ventilator strategies.&#xD;
&#xD;
      In this study the investigators aim to compare primary extubation failure rates in&#xD;
      infants/participants managed by NIPPV vs. NI-NAVA (non invasive NAVA). Eligible&#xD;
      infants/participants will be randomized to be extubated to predefined NIPPV or NI-NAVA&#xD;
      ventilator settings and will be assessed for primary extubation failure (defined as&#xD;
      reintubation within 5 days after an elective extubation).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mechanical ventilation is needed for most preterm infants to maintain adequate oxygenation&#xD;
      and ventilation. However the coexistence of lung immaturity, weak respiratory drive,&#xD;
      excessively compliant chest wall, and surfactant deficiency often contribute to dependency on&#xD;
      mechanical ventilation during the first days or weeks after birth.&#xD;
&#xD;
      Prolonged mechanical ventilation is associated with high mortality and morbidities including&#xD;
      ventilator-associated pneumonia, pneumothorax, and bronchopulmonary dysplasia (BPD). Each&#xD;
      additional week of mechanical ventilation is reported to be associated with an increase in&#xD;
      the risk of neurodevelopmental impairment. Reduction in the need and duration of invasive&#xD;
      mechanical ventilation may potentially improve outcome of preterm infants.&#xD;
&#xD;
      Extubation failure has been independently associated with increased mortality, longer&#xD;
      hospitalization, and more days on oxygen and ventilatory support. It is critical, therefore,&#xD;
      to attempt extubation early and at a time when successful extubation is likely.&#xD;
&#xD;
      A recent Cochrane review compared the use of nasal intermittent positive pressure ventilation&#xD;
      (NIPPV) with nasal continuous positive airway pressure (nCPAP) in preterm infants after&#xD;
      extubation and found that NIPPV may be more effective than nCPAP at decreasing extubation&#xD;
      failure.&#xD;
&#xD;
      The feasibility of NAVA use has been described in neonatal and pediatric patients. Several&#xD;
      studies cite a decrease in peak inspiratory pressures, improved synchrony in triggering, and&#xD;
      more appropriate termination of positive pressure support. Some studies have reported lower&#xD;
      work of breathing, PaO2/FiO2 ratios (partial pressure of oxygen/ fractional inspired&#xD;
      oxygen)and MAP. In addition, NAVA has been used for patients who &quot;fight the ventilator,&quot; and&#xD;
      the synchrony improves the ability to wean.&#xD;
&#xD;
      The use of NIV-NAVA in neonates has promise as a primary mode of ventilation to aid in the&#xD;
      prevention of intubation and also maintaining successful extubation. Early extubation may be&#xD;
      enhanced with NIV-NAVA of those neonates requiring intubation for numerous reasons. The&#xD;
      ability to provide synchronous NIV allows clinicians the opportunity to extubate infants&#xD;
      earlier with increased confidence than with previous post extubation support.&#xD;
&#xD;
      However there is lack of scientific evidence on extubation failure rates on NI-NAVA. Trials&#xD;
      comparing NAVA to conventional ventilators with regard to ventilator associated lung injury,&#xD;
      ventilator associated pneumonia and decreasing duration of time on the ventilator have not&#xD;
      yet been reported.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2017</start_date>
  <completion_date type="Actual">September 5, 2019</completion_date>
  <primary_completion_date type="Actual">September 5, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>provider and PI is masked for randomization but then no masking once treatment (mode of ventilation) is applied</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Extubation success</measure>
    <time_frame>5 days</time_frame>
    <description>assess how many infants stayed extubated at 5 days after extubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bronchopulmonary dysplasia (BPD)</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>based on NIH guidelines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator Days</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>days on positive pressure ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NICU length of stay</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>discharge or death or transfer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patent ductus arteriosus (PDA)</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>echo diagnosed/confirmed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Necrotizing enterocolitis (NEC</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>confirmed on Xray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late onset sepsis</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>only culture proven</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal perforation</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>confirmed on X-ray or surgical exploration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>all causes within NICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extubation failure at 3 days</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>reintubation by 72 hrs. post extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extubation failure at 7 days</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>reintubation by 72 hrs. post extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary air leak</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>including pulmonary interstitial emphysema (PIE) pneumomediastinum and pneumothorax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe intraventricular hemorrhage</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>on cranial ultrasound, worst grade</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal distension &gt; 2cm from baseline and with signs necessitating cessation of feeds during the first 48 hrs. after extubation</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>during the first 48 hrs. after extubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinopathy of prematurity (ROP)</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>ophthalmologic exam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator associated Pneumonia (VAP)</measure>
    <time_frame>until discharge / 36 weeks post menstrual age</time_frame>
    <description>diagnosed based on tracheal culture + CXR changes + clinical worsening + treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Preterm Infant</condition>
  <condition>BPD - Bronchopulmonary Dysplasia</condition>
  <condition>Barotrauma</condition>
  <arm_group>
    <arm_group_label>NI-NAVA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wait to meet extubation criteria within 14 days postnatal age&#xD;
Pre-extubation mode of invasive ventilation will be per physician discretion (NAVA, CMV, high frequency oscillator ventilation (HFOV) or high frequency jet ventilation (HFJV)) Pi to determine eligibility or exclusion&#xD;
Randomize to either NIPPV or NI-NAVA, 1:1 randomization&#xD;
PI will not be blinded to the intervention (not feasible)&#xD;
If extubating to NAVA then place the catheter to optimize position and Edi 1 hr. prior to planned extubation.&#xD;
ABG or CBG to be obtained at 4 hrs. post extubation&#xD;
NI-NAVA settings will be weaned or increased as the clinical situation demands and outlined in the protocol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NIPPV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wait to meet extubation criteria within 14 days postnatal age&#xD;
Pre-extubation mode of invasive ventilation will be per physician discretion (NAVA, CMV, high frequency oscillator ventilation (HFOV) or high frequency jet ventilation (HFJV)) PI to determine eligibility or exclusion&#xD;
Randomize to either NIPPV or NI-NAVA, 1:1 randomization&#xD;
PI will not be blinded to the intervention (not feasible)&#xD;
ABG or CBG to be obtained at 4 hrs. post extubation&#xD;
NIPPV settings will be weaned or increased as the clinical situation demands and outlined in the protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NAVA</intervention_name>
    <description>Infant will be extubated to NAVA, settings based per protocol</description>
    <arm_group_label>NI-NAVA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NIPPV</intervention_name>
    <description>Infant will be extubated to NIPPV, settings detailed in protocol</description>
    <arm_group_label>NIPPV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Infants born between 24 weeks and ≤ 32 weeks completed gestational age or birth weight&#xD;
             less than or equal to 1500 grams&#xD;
&#xD;
          2. Postnatal age ≤ 14 days&#xD;
&#xD;
          3. Inborn&#xD;
&#xD;
          4. Mechanically ventilated for at least 12 hrs.&#xD;
&#xD;
          5. Intubated within first 24 hrs. after birth&#xD;
&#xD;
          6. Outborn infants intubated and transferred to UF within 24 hrs. after birth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Outborn &gt; 24hrs of age.&#xD;
&#xD;
          2. Failed elective extubation prior to study enrollment&#xD;
&#xD;
          3. Major congenital anomalies or known/suspected chromosomal anomalies&#xD;
&#xD;
          4. Use of paralytics in previous 24 hrs.&#xD;
&#xD;
          5. Participation in another randomized interventional trial&#xD;
&#xD;
          6. Known or suspected phrenic nerve palsy or lesion&#xD;
&#xD;
          7. Known or suspected diaphragmatic lesion&#xD;
&#xD;
          8. Any contraindication to have a nasogastric or orogastric tube placement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Weeks</minimum_age>
    <maximum_age>32 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sanket Shah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Firestone KS, Beck J, Stein H. Neurally Adjusted Ventilatory Assist for Noninvasive Support in Neonates. Clin Perinatol. 2016 Dec;43(4):707-724. doi: 10.1016/j.clp.2016.07.007.</citation>
    <PMID>27837754</PMID>
  </reference>
  <reference>
    <citation>LoVerde B, Firestone KS, Stein HM. Comparing changing neurally adjusted ventilatory assist (NAVA) levels in intubated and recently extubated neonates. J Perinatol. 2016 Dec;36(12):1097-1100. doi: 10.1038/jp.2016.152. Epub 2016 Sep 15.</citation>
    <PMID>27629375</PMID>
  </reference>
  <reference>
    <citation>Firestone KS, Fisher S, Reddy S, White DB, Stein HM. Effect of changing NAVA levels on peak inspiratory pressures and electrical activity of the diaphragm in premature neonates. J Perinatol. 2015 Aug;35(8):612-6. doi: 10.1038/jp.2015.14. Epub 2015 Mar 12.</citation>
    <PMID>25764328</PMID>
  </reference>
  <reference>
    <citation>Stein H, Firestone K. Application of neurally adjusted ventilatory assist in neonates. Semin Fetal Neonatal Med. 2014 Feb;19(1):60-9. doi: 10.1016/j.siny.2013.09.005. Epub 2013 Nov 13.</citation>
    <PMID>24238745</PMID>
  </reference>
  <reference>
    <citation>Stein H, Firestone K, Rimensberger PC. Synchronized mechanical ventilation using electrical activity of the diaphragm in neonates. Clin Perinatol. 2012 Sep;39(3):525-42. doi: 10.1016/j.clp.2012.06.004.</citation>
    <PMID>22954267</PMID>
  </reference>
  <reference>
    <citation>Lemyre B, Davis PG, De Paoli AG, Kirpalani H. Nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive airway pressure (NCPAP) for preterm neonates after extubation. Cochrane Database Syst Rev. 2017 Feb 1;2(2):CD003212. doi: 10.1002/14651858.CD003212.pub3.</citation>
    <PMID>28146296</PMID>
  </reference>
  <reference>
    <citation>Lee J, Kim HS, Jung YH, Shin SH, Choi CW, Kim EK, Kim BI, Choi JH. Non-invasive neurally adjusted ventilatory assist in preterm infants: a randomised phase II crossover trial. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F507-13. doi: 10.1136/archdischild-2014-308057. Epub 2015 Jul 15.</citation>
    <PMID>26178463</PMID>
  </reference>
  <reference>
    <citation>Baudin F, Pouyau R, Cour-Andlauer F, Berthiller J, Robert D, Javouhey E. Neurally adjusted ventilator assist (NAVA) reduces asynchrony during non-invasive ventilation for severe bronchiolitis. Pediatr Pulmonol. 2015 Dec;50(12):1320-7. doi: 10.1002/ppul.23139. Epub 2014 Dec 8.</citation>
    <PMID>25488197</PMID>
  </reference>
  <reference>
    <citation>Bhandari V. Nasal intermittent positive pressure ventilation in the newborn: review of literature and evidence-based guidelines. J Perinatol. 2010 Aug;30(8):505-12. doi: 10.1038/jp.2009.165. Epub 2009 Oct 22. Erratum In: J Perinatol. 2010 Dec;30(12):827.</citation>
    <PMID>19847188</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>February 17, 2020</last_update_submitted>
  <last_update_submitted_qc>February 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NAVA</keyword>
  <keyword>Extubation</keyword>
  <keyword>NIPPV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
    <mesh_term>Barotrauma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03242057
org study id: IRB201701971
nct id: NCT03242057
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Extubation failure is a significant problem in preterm neonates and prolonged intubation is a
      well-documented risk factor for development of chronic lung disease. Out of the respiratory
      modalities available to extubate a preterm neonate; high flow nasal canula, nasal continuous
      positive airway pressure (nCPAP) and noninvasive positive pressure ventilation (NIPPV) are
      the most commonly used.

      A recent Cochrane meta-analysis concluded that NIPPV has lower extubation failure as compared
      to nCPAP (30% vs. 40%)

      NAVA (neurally adjusted ventilatory assist), a relatively new mode of mechanical ventilation
      in which the diaphragmatic electrical activity initiates a ventilator breath and adjustment
      of a preset gain (NAVA level) determines the peak inspiratory pressure. It has been reported
      to improve patient - ventilator synchrony and minimize mean airway pressure and ability to
      wean an infant from a ventilator. However till date there has been no head to head comparison
      of extubation failure in infants managed on NAVA with conventional ventilator strategies.

      In this study the investigators aim to compare primary extubation failure rates in
      infants/participants managed by NIPPV vs. NI-NAVA (non invasive NAVA). Eligible
      infants/participants will be randomized to be extubated to predefined NIPPV or NI-NAVA
      ventilator settings and will be assessed for primary extubation failure (defined as
      reintubation within 5 days after an elective extubation).
Mechanical ventilation is needed for most preterm infants to maintain adequate oxygenation
      and ventilation. However the coexistence of lung immaturity, weak respiratory drive,
      excessively compliant chest wall, and surfactant deficiency often contribute to dependency on
      mechanical ventilation during the first days or weeks after birth.

      Prolonged mechanical ventilation is associated with high mortality and morbidities including
      ventilator-associated pneumonia, pneumothorax, and bronchopulmonary dysplasia (BPD). Each
      additional week of mechanical ventilation is reported to be associated with an increase in
      the risk of neurodevelopmental impairment. Reduction in the need and duration of invasive
      mechanical ventilation may potentially improve outcome of preterm infants.

      Extubation failure has been independently associated with increased mortality, longer
      hospitalization, and more days on oxygen and ventilatory support. It is critical, therefore,
      to attempt extubation early and at a time when successful extubation is likely.

      A recent Cochrane review compared the use of nasal intermittent positive pressure ventilation
      (NIPPV) with nasal continuous positive airway pressure (nCPAP) in preterm infants after
      extubation and found that NIPPV may be more effective than nCPAP at decreasing extubation
      failure.

      The feasibility of NAVA use has been described in neonatal and pediatric patients. Several
      studies cite a decrease in peak inspiratory pressures, improved synchrony in triggering, and
      more appropriate termination of positive pressure support. Some studies have reported lower
      work of breathing, PaO2/FiO2 ratios (partial pressure of oxygen/ fractional inspired
      oxygen)and MAP. In addition, NAVA has been used for patients who "fight the ventilator," and
      the synchrony improves the ability to wean.

      The use of NIV-NAVA in neonates has promise as a primary mode of ventilation to aid in the
      prevention of intubation and also maintaining successful extubation. Early extubation may be
      enhanced with NIV-NAVA of those neonates requiring intubation for numerous reasons. The
      ability to provide synchronous NIV allows clinicians the opportunity to extubate infants
      earlier with increased confidence than with previous post extubation support.

      However there is lack of scientific evidence on extubation failure rates on NI-NAVA. Trials
      comparing NAVA to conventional ventilators with regard to ventilator associated lung injury,
      ventilator associated pneumonia and decreasing duration of time on the ventilator have not
      yet been reported.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: provider and PI is masked for randomization but then no masking once treatment (mode of ventilation) is applied
measure: Extubation success
time frame: 5 days
description: assess how many infants stayed extubated at 5 days after extubation
measure: Bronchopulmonary dysplasia (BPD)
time frame: until discharge / 36 weeks post menstrual age
description: based on NIH guidelines
measure: Ventilator Days
time frame: until discharge / 36 weeks post menstrual age
description: days on positive pressure ventilation
measure: NICU length of stay
time frame: until discharge / 36 weeks post menstrual age
description: discharge or death or transfer
measure: Patent ductus arteriosus (PDA)
time frame: until discharge / 36 weeks post menstrual age
description: echo diagnosed/confirmed
measure: Necrotizing enterocolitis (NEC
time frame: until discharge / 36 weeks post menstrual age
description: confirmed on Xray
measure: Late onset sepsis
time frame: until discharge / 36 weeks post menstrual age
description: only culture proven
measure: Gastrointestinal perforation
time frame: until discharge / 36 weeks post menstrual age
description: confirmed on X-ray or surgical exploration
measure: Mortality
time frame: until discharge / 36 weeks post menstrual age
description: all causes within NICU stay
measure: Extubation failure at 3 days
time frame: until discharge / 36 weeks post menstrual age
description: reintubation by 72 hrs. post extubation
measure: Extubation failure at 7 days
time frame: until discharge / 36 weeks post menstrual age
description: reintubation by 72 hrs. post extubation
measure: Pulmonary air leak
time frame: until discharge / 36 weeks post menstrual age
description: including pulmonary interstitial emphysema (PIE) pneumomediastinum and pneumothorax
measure: Severe intraventricular hemorrhage
time frame: until discharge / 36 weeks post menstrual age
description: on cranial ultrasound, worst grade
measure: Abdominal distension > 2cm from baseline and with signs necessitating cessation of feeds during the first 48 hrs. after extubation
time frame: until discharge / 36 weeks post menstrual age
description: during the first 48 hrs. after extubation
measure: Retinopathy of prematurity (ROP)
time frame: until discharge / 36 weeks post menstrual age
description: ophthalmologic exam
measure: Ventilator associated Pneumonia (VAP)
time frame: until discharge / 36 weeks post menstrual age
description: diagnosed based on tracheal culture + CXR changes + clinical worsening + treatment
arm group label: NI-NAVA
arm group type: Experimental
description: Wait to meet extubation criteria within 14 days postnatal age
Pre-extubation mode of invasive ventilation will be per physician discretion (NAVA, CMV, high frequency oscillator ventilation (HFOV) or high frequency jet ventilation (HFJV)) Pi to determine eligibility or exclusion
Randomize to either NIPPV or NI-NAVA, 1:1 randomization
PI will not be blinded to the intervention (not feasible)
If extubating to NAVA then place the catheter to optimize position and Edi 1 hr. prior to planned extubation.
ABG or CBG to be obtained at 4 hrs. post extubation
NI-NAVA settings will be weaned or increased as the clinical situation demands and outlined in the protocol
arm group label: NIPPV
arm group type: Active Comparator
description: Wait to meet extubation criteria within 14 days postnatal age
Pre-extubation mode of invasive ventilation will be per physician discretion (NAVA, CMV, high frequency oscillator ventilation (HFOV) or high frequency jet ventilation (HFJV)) PI to determine eligibility or exclusion
Randomize to either NIPPV or NI-NAVA, 1:1 randomization
PI will not be blinded to the intervention (not feasible)
ABG or CBG to be obtained at 4 hrs. post extubation
NIPPV settings will be weaned or increased as the clinical situation demands and outlined in the protocol
intervention type: Other
intervention name: NAVA
description: Infant will be extubated to NAVA, settings based per protocol
arm group label: NI-NAVA
intervention type: Other
intervention name: NIPPV
description: Infant will be extubated to NIPPV, settings detailed in protocol
arm group label: NIPPV
criteria: 
gender: All
minimum age: 24 Weeks
maximum age: 32 Weeks
healthy volunteers: No
last name: Sanket Shah, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
citation: Firestone KS, Beck J, Stein H. Neurally Adjusted Ventilatory Assist for Noninvasive Support in Neonates. Clin Perinatol. 2016 Dec;43(4):707-724. doi: 10.1016/j.clp.2016.07.007.
PMID: 27837754
citation: LoVerde B, Firestone KS, Stein HM. Comparing changing neurally adjusted ventilatory assist (NAVA) levels in intubated and recently extubated neonates. J Perinatol. 2016 Dec;36(12):1097-1100. doi: 10.1038/jp.2016.152. Epub 2016 Sep 15.
PMID: 27629375
citation: Firestone KS, Fisher S, Reddy S, White DB, Stein HM. Effect of changing NAVA levels on peak inspiratory pressures and electrical activity of the diaphragm in premature neonates. J Perinatol. 2015 Aug;35(8):612-6. doi: 10.1038/jp.2015.14. Epub 2015 Mar 12.
PMID: 25764328
citation: Stein H, Firestone K. Application of neurally adjusted ventilatory assist in neonates. Semin Fetal Neonatal Med. 2014 Feb;19(1):60-9. doi: 10.1016/j.siny.2013.09.005. Epub 2013 Nov 13.
PMID: 24238745
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responsible party type: Sponsor
mesh term: Bronchopulmonary Dysplasia
mesh term: Barotrauma
sharing ipd: No