Preterm InfantNCT03242057
Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA
A study testing NAVA and NIPPV in people with Preterm Infant and BPD - Bronchopulmonary Dysplasia, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 24 to 32 weeks
- Conditions the study is for
- Preterm Infant, BPD - Bronchopulmonary Dysplasia, Barotrauma
- What is being tested?
- NAVA and NIPPV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2017to 5 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Primary Extubation Failure Between Non-invasive Positive Pressure Ventilation (NIPPV) and Non Invasive Neural Access Ventilatory Assist (NI-NAVA)
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%)
Read more
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).
Read the 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.
- Conditions
- Preterm Infant, BPD - Bronchopulmonary Dysplasia, Barotrauma
- Being tested
- NAVA, NIPPV
- Keywords
- NAVA, Extubation, NIPPV
- Medical subject headings
- Premature Birth, Bronchopulmonary Dysplasia, Barotrauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAVAOther
Infant will be extubated to NAVA, settings based per protocol
NIPPVOther
Infant will be extubated to NIPPV, settings detailed in protocol
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: NIPPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation success
assess how many infants stayed extubated at 5 days after extubation
Measured: 5 days
Secondary outcomes (15)
Bronchopulmonary dysplasia (BPD)
based on NIH guidelines
Measured: until discharge / 36 weeks post menstrual age
Ventilator Days
days on positive pressure ventilation
Measured: until discharge / 36 weeks post menstrual age
NICU length of stay
discharge or death or transfer
Measured: until discharge / 36 weeks post menstrual age
Patent ductus arteriosus (PDA)
echo diagnosed/confirmed
Measured: until discharge / 36 weeks post menstrual age
Necrotizing enterocolitis (NEC
confirmed on Xray
Measured: until discharge / 36 weeks post menstrual age
Late onset sepsis
only culture proven
Measured: until discharge / 36 weeks post menstrual age
Gastrointestinal perforation
confirmed on X-ray or surgical exploration
Measured: until discharge / 36 weeks post menstrual age
Mortality
all causes within NICU stay
Measured: until discharge / 36 weeks post menstrual age
Extubation failure at 3 days
reintubation by 72 hrs. post extubation
Measured: until discharge / 36 weeks post menstrual age
Extubation failure at 7 days
reintubation by 72 hrs. post extubation
Measured: until discharge / 36 weeks post menstrual age
Pulmonary air leak
including pulmonary interstitial emphysema (PIE) pneumomediastinum and pneumothorax
Measured: until discharge / 36 weeks post menstrual age
Severe intraventricular hemorrhage
on cranial ultrasound, worst grade
Measured: until discharge / 36 weeks post menstrual age
Abdominal distension > 2cm from baseline and with signs necessitating cessation of feeds during the first 48 hrs. after extubation
during the first 48 hrs. after extubation
Measured: until discharge / 36 weeks post menstrual age
Retinopathy of prematurity (ROP)
ophthalmologic exam
Measured: until discharge / 36 weeks post menstrual age
Ventilator associated Pneumonia (VAP)
diagnosed based on tracheal culture + CXR changes + clinical worsening + treatment
Measured: until discharge / 36 weeks post menstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start23 Oct 2017
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanket Shah, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242057
- Sponsor's protocol ID
- IRB201701971
- Status last verified
- Feb 2020
- First submitted
- 28 Jul 2017
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27837754LoVerde 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.
PubMed 27629375Firestone 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.
PubMed 25764328Stein 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.
PubMed 24238745Stein 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.
PubMed 22954267Lemyre 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.
PubMed 28146296Lee 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.
PubMed 26178463Baudin 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.
PubMed 25488197Bhandari 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.
PubMed 19847188
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Primary Extubation Failure Between Non-invasive Positive Pressure Ventilation (NIPPV) and Non Invasive Neural Access Ventilatory Assist (NI-NAVA)
- ClinicalTrials.gov ID
- NCT03242057
- Acronym / sponsor ID
- IRB201701971
- Conditions
- Preterm Infant, BPD - Bronchopulmonary Dysplasia, Barotrauma
- Keywords
- NAVA, Extubation, NIPPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NI-NAVA | Experimental | Other: 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 |
| NIPPV | Active comparator | Other: NIPPVWait 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 |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAVAInfant will be extubated to NAVA, settings based per protocol | Other | NI-NAVA |
| NIPPVInfant will be extubated to NIPPV, settings detailed in protocol | Other | NIPPV |
Primary outcome
Extubation success
Time frame: 5 days
assess how many infants stayed extubated at 5 days after extubation
15 secondary outcomes
Bronchopulmonary dysplasia (BPD)
Time frame: until discharge / 36 weeks post menstrual age
Ventilator Days
Time frame: until discharge / 36 weeks post menstrual age
NICU length of stay
Time frame: until discharge / 36 weeks post menstrual age
Patent ductus arteriosus (PDA)
Time frame: until discharge / 36 weeks post menstrual age
Necrotizing enterocolitis (NEC
Time frame: until discharge / 36 weeks post menstrual age
Late onset sepsis
Time frame: until discharge / 36 weeks post menstrual age
Gastrointestinal perforation
Time frame: until discharge / 36 weeks post menstrual age
Mortality
Time frame: until discharge / 36 weeks post menstrual age
Extubation failure at 3 days
Time frame: until discharge / 36 weeks post menstrual age
Extubation failure at 7 days
Time frame: until discharge / 36 weeks post menstrual age
Pulmonary air leak
Time frame: until discharge / 36 weeks post menstrual age
Severe intraventricular hemorrhage
Time frame: until discharge / 36 weeks post menstrual age
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
Retinopathy of prematurity (ROP)
Time frame: until discharge / 36 weeks post menstrual age
Ventilator associated Pneumonia (VAP)
Time frame: until discharge / 36 weeks post menstrual age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Background: PubMed 27837754Firestone 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.
- Background: PubMed 27629375LoVerde 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.
- Background: PubMed 25764328Firestone 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.
- Background: PubMed 24238745Stein 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.
- Background: PubMed 22954267Stein 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.
- Background: PubMed 28146296Lemyre 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.
- Background: PubMed 26178463Lee 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.
- Background: PubMed 25488197Baudin 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.
- Background: PubMed 19847188Bhandari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanket Shah, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NAVA and NIPPV in people with Preterm Infant and BPD - Bronchopulmonary Dysplasia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation success (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03242057, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.