Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-04-17 @ 12:16 AM
Study NCT ID:
NCT03242057
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2017-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D001469', 'term': 'Barotrauma'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'provider and PI is masked for randomization but then no masking once treatment (mode of ventilation) is applied'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-17', 'studyFirstSubmitDate': '2017-07-28', 'studyFirstSubmitQcDate': '2017-08-01', 'lastUpdatePostDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extubation success', 'timeFrame': '5 days', 'description': 'assess how many infants stayed extubated at 5 days after extubation'}], 'secondaryOutcomes': [{'measure': 'Bronchopulmonary dysplasia (BPD)', 'timeFrame': 'until discharge / 36 weeks post menstrual age', 'description': 'based on NIH guidelines'}, {'measure': 'Ventilator Days', 'timeFrame': 'until discharge / 36 weeks post menstrual age', 'description': 'days on positive pressure ventilation'}, {'measure': 'NICU length of stay', 'timeFrame': 'until discharge / 36 weeks post menstrual age', 'description': 'discharge or death or transfer'}, {'measure': 'Patent ductus arteriosus (PDA)', 'timeFrame': 'until discharge / 36 weeks post menstrual age', 'description': 'echo diagnosed/confirmed'}, {'measure': 'Necrotizing enterocolitis (NEC', 'timeFrame': 'until discharge / 36 weeks post menstrual age', 'description': 'confirmed on Xray'}, {'measure': 'Late onset sepsis', 'timeFrame': 'until discharge / 36 weeks post menstrual age', 'description': 'only culture proven'}, {'measure': 'Gastrointestinal perforation', 'timeFrame': 'until discharge / 36 weeks post menstrual age', 'description': 'confirmed on X-ray or surgical exploration'}, {'measure': 'Mortality', 'timeFrame': 'until discharge / 36 weeks post menstrual age', 'description': 'all causes within NICU stay'}, {'measure': 'Extubation failure at 3 days', 'timeFrame': 'until discharge / 36 weeks post menstrual age', 'description': 'reintubation by 72 hrs. post extubation'}, {'measure': 'Extubation failure at 7 days', 'timeFrame': 'until discharge / 36 weeks post menstrual age', 'description': 'reintubation by 72 hrs. post extubation'}, {'measure': 'Pulmonary air leak', 'timeFrame': 'until discharge / 36 weeks post menstrual age', 'description': 'including pulmonary interstitial emphysema (PIE) pneumomediastinum and pneumothorax'}, {'measure': 'Severe intraventricular hemorrhage', 'timeFrame': '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', 'timeFrame': 'until discharge / 36 weeks post menstrual age', 'description': 'during the first 48 hrs. after extubation'}, {'measure': 'Retinopathy of prematurity (ROP)', 'timeFrame': 'until discharge / 36 weeks post menstrual age', 'description': 'ophthalmologic exam'}, {'measure': 'Ventilator associated Pneumonia (VAP)', 'timeFrame': 'until discharge / 36 weeks post menstrual age', 'description': 'diagnosed based on tracheal culture + CXR changes + clinical worsening + treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NAVA', 'Extubation', 'NIPPV'], 'conditions': ['Preterm Infant', 'BPD - Bronchopulmonary Dysplasia', 'Barotrauma']}, 'referencesModule': {'references': [{'pmid': '27837754', 'type': 'BACKGROUND', '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': '27629375', 'type': 'BACKGROUND', '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': '25764328', 'type': 'BACKGROUND', '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': '24238745', 'type': 'BACKGROUND', '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': '22954267', 'type': 'BACKGROUND', '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.'}, {'pmid': '28146296', 'type': 'BACKGROUND', '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.'}, {'pmid': '26178463', 'type': 'BACKGROUND', '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.'}, {'pmid': '25488197', 'type': 'BACKGROUND', '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.'}, {'pmid': '19847188', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nA recent Cochrane meta-analysis concluded that NIPPV has lower extubation failure as compared to nCPAP (30% vs. 40%)\n\nNAVA (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.\n\nIn 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).', 'detailedDescription': '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.\n\nProlonged 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.\n\nExtubation 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.\n\nA 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.\n\nThe 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.\n\nThe 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.\n\nHowever 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'minimumAge': '24 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Infants born between 24 weeks and ≤ 32 weeks completed gestational age or birth weight less than or equal to 1500 grams\n2. Postnatal age ≤ 14 days\n3. Inborn\n4. Mechanically ventilated for at least 12 hrs.\n5. Intubated within first 24 hrs. after birth\n6. Outborn infants intubated and transferred to UF within 24 hrs. after birth.\n\nExclusion Criteria:\n\n1. Outborn \\> 24hrs of age.\n2. Failed elective extubation prior to study enrollment\n3. Major congenital anomalies or known/suspected chromosomal anomalies\n4. Use of paralytics in previous 24 hrs.\n5. Participation in another randomized interventional trial\n6. Known or suspected phrenic nerve palsy or lesion\n7. Known or suspected diaphragmatic lesion\n8. Any contraindication to have a nasogastric or orogastric tube placement'}, 'identificationModule': {'nctId': 'NCT03242057', 'briefTitle': 'Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Comparison of Primary Extubation Failure Between Non-invasive Positive Pressure Ventilation (NIPPV) and Non Invasive Neural Access Ventilatory Assist (NI-NAVA)', 'orgStudyIdInfo': {'id': 'IRB201701971'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NI-NAVA', 'description': '* Wait to meet extubation criteria within 14 days postnatal age\n* 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\n* Randomize to either NIPPV or NI-NAVA, 1:1 randomization\n* PI will not be blinded to the intervention (not feasible)\n* If extubating to NAVA then place the catheter to optimize position and Edi 1 hr. prior to planned extubation.\n* ABG or CBG to be obtained at 4 hrs. post extubation\n* NI-NAVA settings will be weaned or increased as the clinical situation demands and outlined in the protocol', 'interventionNames': ['Other: NAVA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NIPPV', 'description': 'Wait to meet extubation criteria within 14 days postnatal age\n\n* 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\n* Randomize to either NIPPV or NI-NAVA, 1:1 randomization\n* PI will not be blinded to the intervention (not feasible)\n* ABG or CBG to be obtained at 4 hrs. post extubation\n* NIPPV settings will be weaned or increased as the clinical situation demands and outlined in the protocol', 'interventionNames': ['Other: NIPPV']}], 'interventions': [{'name': 'NAVA', 'type': 'OTHER', 'description': 'Infant will be extubated to NAVA, settings based per protocol', 'armGroupLabels': ['NI-NAVA']}, {'name': 'NIPPV', 'type': 'OTHER', 'description': 'Infant will be extubated to NIPPV, settings detailed in protocol', 'armGroupLabels': ['NIPPV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Sanket Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}