Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA

NCT03242057 | Completed DMC

• 1 other identifier: IRB201701971
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Preterm Infant; BPD - Bronchopulmonary Dysplasia; Barotrauma

Keywords

NAVA; Extubation; NIPPV

Outcome Measures

Primary Outcomes (1)

• Extubation success

  assess how many infants stayed extubated at 5 days after extubation

  5 days

Secondary Outcomes (15)

• Bronchopulmonary dysplasia (BPD)

  until discharge / 36 weeks post menstrual age

• Ventilator Days

  until discharge / 36 weeks post menstrual age

• NICU length of stay

  until discharge / 36 weeks post menstrual age

• Patent ductus arteriosus (PDA)

  until discharge / 36 weeks post menstrual age

• Necrotizing enterocolitis (NEC

  until discharge / 36 weeks post menstrual age

Study Arms (2)

NI-NAVA

EXPERIMENTAL

* 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

NIPPV

ACTIVE COMPARATOR

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

Interventions

NAVA OTHER

Infant will be extubated to NAVA, settings based per protocol

NI-NAVA

NIPPV OTHER

Infant will be extubated to NIPPV, settings detailed in protocol

NIPPV

Eligibility Criteria

• Age: 24 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born between 24 weeks and ≤ 32 weeks completed gestational age or birth weight less than or equal to 1500 grams
• Postnatal age ≤ 14 days
• Inborn
• Mechanically ventilated for at least 12 hrs.
• Intubated within first 24 hrs. after birth
• Outborn infants intubated and transferred to UF within 24 hrs. after birth.

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Jacksonville, Florida, 32207, United States

Location

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 22954267 BACKGROUND

• 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.

  PMID: 28146296 BACKGROUND

• 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.

  PMID: 26178463 BACKGROUND

• 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.

  PMID: 25488197 BACKGROUND

• 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.

  PMID: 19847188 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia; Barotrauma

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Study Officials

• Sanket Shah, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: provider and PI is masked for randomization but then no masking once treatment (mode of ventilation) is applied
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 8, 2017
• Study Start: October 23, 2017
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)