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Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA

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ClinicalTrials.gov Identifier: NCT03242057
Recruitment Status : Recruiting
First Posted : August 8, 2017
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Preterm Infant BPD - Bronchopulmonary Dysplasia Barotrauma Other: NAVA Other: NIPPV Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: provider and PI is masked for randomization but then no masking once treatment (mode of ventilation) is applied
Primary Purpose: Treatment
Official Title: Comparison of Primary Extubation Failure Between Non-invasive Positive Pressure Ventilation (NIPPV) and Non Invasive Neural Access Ventilatory Assist (NI-NAVA)
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NI-NAVA
  • 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
Other: NAVA
Infant will be extubated to NAVA, settings based per protocol

Active Comparator: NIPPV

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
Other: NIPPV
Infant will be extubated to NIPPV, settings detailed in protocol




Primary Outcome Measures :
  1. Extubation success [ Time Frame: 5 days ]
    assess how many infants stayed extubated at 5 days after extubation


Secondary Outcome Measures :
  1. Bronchopulmonary dysplasia (BPD) [ Time Frame: until discharge / 36 weeks post menstrual age ]
    based on NIH guidelines

  2. Ventilator Days [ Time Frame: until discharge / 36 weeks post menstrual age ]
    days on positive pressure ventilation

  3. NICU length of stay [ Time Frame: until discharge / 36 weeks post menstrual age ]
    discharge or death or transfer

  4. Patent ductus arteriosus (PDA) [ Time Frame: until discharge / 36 weeks post menstrual age ]
    echo diagnosed/confirmed

  5. Necrotizing enterocolitis (NEC [ Time Frame: until discharge / 36 weeks post menstrual age ]
    confirmed on Xray

  6. Late onset sepsis [ Time Frame: until discharge / 36 weeks post menstrual age ]
    only culture proven

  7. Gastrointestinal perforation [ Time Frame: until discharge / 36 weeks post menstrual age ]
    confirmed on X-ray or surgical exploration

  8. Mortality [ Time Frame: until discharge / 36 weeks post menstrual age ]
    all causes within NICU stay

  9. Extubation failure at 3 days [ Time Frame: until discharge / 36 weeks post menstrual age ]
    reintubation by 72 hrs. post extubation

  10. Extubation failure at 7 days [ Time Frame: until discharge / 36 weeks post menstrual age ]
    reintubation by 72 hrs. post extubation

  11. Pulmonary air leak [ Time Frame: until discharge / 36 weeks post menstrual age ]
    including pulmonary interstitial emphysema (PIE) pneumomediastinum and pneumothorax

  12. Severe intraventricular hemorrhage [ Time Frame: until discharge / 36 weeks post menstrual age ]
    on cranial ultrasound, worst grade

  13. 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 ]
    during the first 48 hrs. after extubation

  14. Retinopathy of prematurity (ROP) [ Time Frame: until discharge / 36 weeks post menstrual age ]
    ophthalmologic exam

  15. Ventilator associated Pneumonia (VAP) [ Time Frame: until discharge / 36 weeks post menstrual age ]
    diagnosed based on tracheal culture + CXR changes + clinical worsening + treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   24 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infants born between 24 weeks and ≤ 32 weeks completed gestational age or birth weight less than or equal to 1500 grams
  2. Postnatal age ≤ 14 days
  3. Inborn
  4. Mechanically ventilated for at least 24 hrs.
  5. Intubated within first 24 hrs. after birth
  6. Outborn infants intubated and transferred to UF within 24 hrs. after birth.

Exclusion Criteria:

  1. Outborn > 24hrs of age.
  2. Failed elective extubation prior to study enrollment
  3. Major congenital anomalies or known/suspected chromosomal anomalies
  4. Use of paralytics in previous 24 hrs.
  5. Participation in another randomized interventional trial
  6. Known or suspected phrenic nerve palsy or lesion
  7. Known or suspected diaphragmatic lesion
  8. Any contraindication to have a nasogastric or orogastric tube placement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03242057


Contacts
Contact: Kartikeya Makker, MD 9042443508 kartikeya.makker@jax.ufl.edu
Contact: Kimberly Barnette 9042445566 kimberly.barnette@jax.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Jacksonville, Florida, United States, 32207
Contact: Kartikeya Makker, MD    904-244-3508    kartikeya.makker@jax.ufl.edu   
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Kartikeya Makker, MD University of Florida

Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03242057     History of Changes
Other Study ID Numbers: IRB201701971
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
NAVA
Extubation
NIPPV

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Barotrauma
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Wounds and Injuries