Inadequate; Pulmonary Ventilation, NewbornNCT01785563
Nasal Noninvasive NAVA in the Very Low Birth Weight Infant
A study testing Nasal NIV-NAVA in people with Inadequate; Pulmonary Ventilation, Newborn and Infant, Very Low Birth Weight, run by Tarah T Colaizy at 2 sites in United States.
Trial summary
The purpose of this study is to determine if a new type of mechanical ventilation, or breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide additional support to infants who were born prematurely. Read more about this study
- Who is it for?
- Ages 7 days to 1 year
- Conditions the study is for
- Inadequate; Pulmonary Ventilation, Newborn, Infant, Very Low Birth Weight
- What is being tested?
- Nasal NIV-NAVA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 days to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- birth weight less than 1,500 grams
- Clinical history of respiratory distress syndrome treated with surfactant
- Chronological age greater than or equal to seven days
- 48 hours post-extubation or greater
- Medically stable per primary medical team
- Receiving ventilatory support on one of the following systems via nasal pharyngeal tube or nasal prongs:continuous positive airway pressure (CPAP), intermittent mechanical ventilation (IMV), or neutrally adjusted ventilatory assistance (NAVA)
- Receiving ventilatory support via high flow nasal cannula if the flow is large enough to provide a positive end expiratory pressure (PEEP) of 6 as defined by PEEP of 6 = 0.68 * weight (kg) + 0.92
- Capillary blood gas via heel stick within 24 hours that demonstrates a pH of less than or equal to 7.35 and/or a partial pressure of carbon dioxide (pCO2) greater than or equal to 45 mmHg
Who cannot join
- Severe congenital abnormalities
- Grade III or IV interventricular hemorrhage.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Iowa NICU
Iowa City, Iowa, 52242
University of Iowa
Iowa City, Iowa, 52242
About this study
Official title: Nasal Noninvasive NAVA Provides Ventilation in the Very Low Birth Weight Infant
The purpose of this study is to determine if a new type of mechanical ventilation, or breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide additional support to infants who were born prematurely. Investigators are looking to determine if in two hours infants who weighed less than 1500 grams or 3 pounds 5 ounces, will demonstrate a decrease in the amount of carbon dioxide (the gas that humans exhale) dissolved in their blood as compared to prior to starting the study. This will be accomplished by enrolling infants who are stable on their current type of mechanical breathing that provides a constant air flow into the infant. This type of mechanical support helps keep the lungs inflated but does not help remove carbon dioxide. This study will change the type of mechanical support to a type of support called neurally adjusted ventilatory assist or NAVA. This type of mechanical support detects when the infant is breathing in by having electrical sensors on a feeding tube that is placed into the stomach through the nose or mouth. These electrical sensors detect when the diaphragm or the muscle that helps humans breath is trying to take a breath in. When the NAVA ventilator senses the attempt to breath, it provides additional air flow to make the effort of breathing easier. The ventilator will be attached to a tube or cannula that is placed into the infant's nose. After two hours of being on the NAVA ventilator a repeat measure of carbon dioxide in the blood will be performed by taking a small amount of blood from the infant's heel.
Read the detailed description
Baseline Data Collection:
Demographic data: Patient gestational age at delivery, maternal betamethasone therapy, APGAR scores, admission weight, receipt of surfactant administered, age at extubation, time since extubation, current post menstrual age, and current weight.
Baseline vitals and ventilation mode: Heart rate, blood pressure, FiO2 (fraction of inspired oxygen), oxygen saturations, transcutaneous partial pressure of carbon dioxide (TCO2) and current mode of ventilation will be recorded four times in a one minute period and the values average to minimize normal variation. Intervention time will be manipulated to begin no later than one hour after the previous feeding, as to minimize interruption of feedings to no greater than 30 minutes.
Safety Safety: TCO2 monitor will be attached to the infant and the device will be calibrated according to protocol (reference TCO2 monitor manual). Carbon dioxide diffusion through the skin will be monitored continuously during the intervention (Bromley 08) to avoid periods of hypo or hypercarbia.
Edi (electrical activity of the diaphragm) Catheter placement: Edi catheter size will be selected according to infant's weight and length. It will be inserted according to manufacturer's guidelines and adjustments will be made to optimize positioning (reference NAVA manual).
NAVA settings:
Infants will be maintained on previous level of PEEP (positive end expiratory pressure) or calculated PEEP, rounding up to whole numbers. Initial NAVA level will be determined by starting with an initial NAVA level of 0.5 microvolts/cm of H20. The NAVA level will then be adjusted either by increasing or decreasing to generate a PIP that is a minimum of 8 cm of H2O greater than the current PEEP. Apnea alarm will be set at 5 seconds, which will initiate the NAVA back up setting if no electrical activity is detected by the Edi catheter. Back up NAVA settings will be set with a PIP of 12 cm of H20 greater than current PEEP, respiratory rate of 60 breaths per minute (RR) and inspiratory time of 0.5 seconds. Fraction of inspired oxygen (FiO2) will be adjusted to keep infant's oxygen saturations within previously established clinical parameters.
Study Intervention Procedure and Data Collection:
At initiation of intervention, and at time 30, 60, 90, and 120 minutes, heart rate (HR), respiratory rate (RR), tidal volume (TV), minute ventilation, FiO2, oxygen saturations, peak Edi and PIP will be recorded four times in a one minute period and the values average to minimize normal variation. Current NAVA settings, TCO2, and blood pressure (BP) will also be recorded. At 60 minutes of intervention if the TCO2 level has not decreased by 5 torr from baseline or has risen, the current NAVA level will be increased by 50%. At 90 minutes if the TCO2 level has not decreased by 5 torr from baseline or has risen; the NAVA level will be increased by 50% from the current level. At the completion of the study (120 minutes or pCO2 outside of established limits) the HR, RR, BP, TV, minute ventilation, FiO2, oxygen saturations, peak Edi and PIP will be recorded four times in a one minute period and the values average to minimize normal variation. A capillary blood gas will be obtained according to standard unit protocol with a warmed heel.
- Being tested
- Nasal NIV-NAVA
- Keywords
- NAVA, NIV-NAVA, VLBW, electrical activity of the diaphragm, neural trigger, mechanical ventilation, respiratory distress syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal NIV-NAVADevice
Also called noninvasive, neurally adjusted ventilatory assist, nasal pharyngeal
Infants will be placed on nasal NIV-NAVA. Patients initial NAVA level will be set to generate a peak inspiratory pressure that is 8 cm of water greater than their current peak end expiratory pressure. If the infants are on nasal NIV-NAVA at the time of study entry their NAVA level will be increased by 50% rounded up to the nearest 0.1 cm of water per microvolt.
| Study group | Role | What they receive |
|---|---|---|
| Nasal NIV-NAVA | Experimental | Infants will be transitioned from their current mode of ventilation to nasal NIV-NAVA. If patients are currently on nasal NIV-NAVA an increase in the NAVA level will be utilized for the intervention. Receives: Device: Nasal NIV-NAVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Partial Pressure of Carbon Dioxide on Capillary Blood Gas
difference between pCO2 (mm Hg) on capillary blood gas obtained within 6 hours of study and immediately after 2 hour study period
Measured: 2 hours
Secondary outcomes (1)
Change in Fraction of Inspired Oxygen
difference between fiO2 at start of study and that at the last measurement timepoint at 120 minutes
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Inadequate; Pulmonary Ventilation, NewbornStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarah T Colaizy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tarah T Colaizy, University of Iowa
- Investigators
- Tarah T Colaizy, M.D., MPH, Principal investigator, University of IowaGary J Kummet, M.D., Study director, University of IowaJonathan C Klein, M.D., Study director, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785563
- Sponsor's protocol ID
- 201208771
- Status last verified
- May 2022
- First submitted
- 1 Feb 2013
- Last updated
- 9 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Breatnach C, Conlon NP, Stack M, Healy M, O'Hare BP. A prospective crossover comparison of neurally adjusted ventilatory assist and pressure-support ventilation in a pediatric and neonatal intensive care unit population. Pediatr Crit Care Med. 2010 Jan;11(1):7-11. doi: 10.1097/PCC.0b013e3181b0630f.
PubMed 19593246de la Oliva P, Schuffelmann C, Gomez-Zamora A, Villar J, Kacmarek RM. Asynchrony, neural drive, ventilatory variability and COMFORT: NAVA versus pressure support in pediatric patients. A non-randomized cross-over trial. Intensive Care Med. 2012 May;38(5):838-46. doi: 10.1007/s00134-012-2535-y. Epub 2012 Apr 6.
PubMed 22481227Clement KC, Thurman TL, Holt SJ, Heulitt MJ. Neurally triggered breaths reduce trigger delay and improve ventilator response times in ventilated infants with bronchiolitis. Intensive Care Med. 2011 Nov;37(11):1826-32. doi: 10.1007/s00134-011-2352-8. Epub 2011 Sep 23.
PubMed 21946913Alander M, Peltoniemi O, Pokka T, Kontiokari T. Comparison of pressure-, flow-, and NAVA-triggering in pediatric and neonatal ventilatory care. Pediatr Pulmonol. 2012 Jan;47(1):76-83. doi: 10.1002/ppul.21519. Epub 2011 Aug 9.
PubMed 21830318Bordessoule A, Emeriaud G, Morneau S, Jouvet P, Beck J. Neurally adjusted ventilatory assist improves patient-ventilator interaction in infants as compared with conventional ventilation. Pediatr Res. 2012 Aug;72(2):194-202. doi: 10.1038/pr.2012.64.
PubMed 22580718Bengtsson JA, Edberg KE. Neurally adjusted ventilatory assist in children: an observational study. Pediatr Crit Care Med. 2010 Mar;11(2):253-7. doi: 10.1097/PCC.0b013e3181b0655e.
PubMed 19593241Lee J, Kim HS, Sohn JA, Lee JA, Choi CW, Kim EK, Kim BI, Choi JH. Randomized crossover study of neurally adjusted ventilatory assist in preterm infants. J Pediatr. 2012 Nov;161(5):808-13. doi: 10.1016/j.jpeds.2012.04.040. Epub 2012 Jun 1.
PubMed 22658785Keszler M. State of the art in conventional mechanical ventilation. J Perinatol. 2009 Apr;29(4):262-75. doi: 10.1038/jp.2009.11. Epub 2009 Feb 26.
PubMed 19242486Stein H, Howard D. Neurally adjusted ventilatory assist in neonates weighing <1500 grams: a retrospective analysis. J Pediatr. 2012 May;160(5):786-9.e1. doi: 10.1016/j.jpeds.2011.10.014. Epub 2011 Dec 3.
PubMed 22137670Stein 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 22954267Beck J, Reilly M, Grasselli G, Mirabella L, Slutsky AS, Dunn MS, Sinderby C. Patient-ventilator interaction during neurally adjusted ventilatory assist in low birth weight infants. Pediatr Res. 2009 Jun;65(6):663-8. doi: 10.1203/PDR.0b013e31819e72ab.
PubMed 19218884Beck J, Brander L, Slutsky AS, Reilly MC, Dunn MS, Sinderby C. Non-invasive neurally adjusted ventilatory assist in rabbits with acute lung injury. Intensive Care Med. 2008 Feb;34(2):316-23. doi: 10.1007/s00134-007-0882-x. Epub 2007 Oct 25.
PubMed 17960364Bertrand PM, Futier E, Coisel Y, Matecki S, Jaber S, Constantin JM. Neurally adjusted ventilatory assist vs pressure support ventilation for noninvasive ventilation during acute respiratory failure: a crossover physiologic study. Chest. 2013 Jan;143(1):30-36. doi: 10.1378/chest.12-0424.
PubMed 22661448Cammarota G, Olivieri C, Costa R, Vaschetto R, Colombo D, Turucz E, Longhini F, Della Corte F, Conti G, Navalesi P. Noninvasive ventilation through a helmet in postextubation hypoxemic patients: physiologic comparison between neurally adjusted ventilatory assist and pressure support ventilation. Intensive Care Med. 2011 Dec;37(12):1943-50. doi: 10.1007/s00134-011-2382-2. Epub 2011 Oct 18.
PubMed 22005826Piquilloud L, Tassaux D, Bialais E, Lambermont B, Sottiaux T, Roeseler J, Laterre PF, Jolliet P, Revelly JP. Neurally adjusted ventilatory assist (NAVA) improves patient-ventilator interaction during non-invasive ventilation delivered by face mask. Intensive Care Med. 2012 Oct;38(10):1624-31. doi: 10.1007/s00134-012-2626-9. Epub 2012 Aug 3.
PubMed 22885649
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Noninvasive NAVA Provides Ventilation in the Very Low Birth Weight Infant
- ClinicalTrials.gov ID
- NCT01785563
- Acronym / sponsor ID
- 201208771
- Keywords
- NAVA, NIV-NAVA, VLBW, electrical activity of the diaphragm, neural trigger, mechanical ventilation, respiratory distress syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tarah T ColaizyUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Posted 9 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if a new type of mechanical ventilation, or breathing machine (called neurally adjusted ventilatory assist or NAVA), will provide additional support to infants who were born prematurely. Investigators are looking to determine if in two hours infants who weighed less than 1500 grams or 3 pounds 5 ounces, will demonstrate a decrease in the amount of carbon dioxide (the gas that humans exhale) dissolved in their blood as compared to prior to starting the study. This will be accomplished by enrolling infants who are stable on their current type of mechanical breathing that provides a constant air flow into the infant. This type of mechanical support helps keep the lungs inflated but does not help remove carbon dioxide. This study will change the type of mechanical support to a type of support called neurally adjusted ventilatory assist or NAVA. This type of mechanical support detects when the infant is breathing in by having electrical sensors on a feeding tube that is placed into the stomach through the nose or mouth. These electrical sensors detect when the diaphragm or the muscle that helps humans breath is trying to take a breath in. When the NAVA ventilator senses the attempt to breath, it provides additional air flow to make the effort of breathing easier. The ventilator will be attached to a tube or cannula that is placed into the infant's nose. After two hours of being on the NAVA ventilator a repeat measure of carbon dioxide in the blood will be performed by taking a small amount of blood from the infant's heel.
Detailed description
Baseline Data Collection:
Demographic data: Patient gestational age at delivery, maternal betamethasone therapy, APGAR scores, admission weight, receipt of surfactant administered, age at extubation, time since extubation, current post menstrual age, and current weight.
Baseline vitals and ventilation mode: Heart rate, blood pressure, FiO2 (fraction of inspired oxygen), oxygen saturations, transcutaneous partial pressure of carbon dioxide (TCO2) and current mode of ventilation will be recorded four times in a one minute period and the values average to minimize normal variation. Intervention time will be manipulated to begin no later than one hour after the previous feeding, as to minimize interruption of feedings to no greater than 30 minutes.
Safety Safety: TCO2 monitor will be attached to the infant and the device will be calibrated according to protocol (reference TCO2 monitor manual). Carbon dioxide diffusion through the skin will be monitored continuously during the intervention (Bromley 08) to avoid periods of hypo or hypercarbia.
Edi (electrical activity of the diaphragm) Catheter placement: Edi catheter size will be selected according to infant's weight and length. It will be inserted according to manufacturer's guidelines and adjustments will be made to optimize positioning (reference NAVA manual).
NAVA settings:
Infants will be maintained on previous level of PEEP (positive end expiratory pressure) or calculated PEEP, rounding up to whole numbers. Initial NAVA level will be determined by starting with an initial NAVA level of 0.5 microvolts/cm of H20. The NAVA level will then be adjusted either by increasing or decreasing to generate a PIP that is a minimum of 8 cm of H2O greater than the current PEEP. Apnea alarm will be set at 5 seconds, which will initiate the NAVA back up setting if no electrical activity is detected by the Edi catheter. Back up NAVA settings will be set with a PIP of 12 cm of H20 greater than current PEEP, respiratory rate of 60 breaths per minute (RR) and inspiratory time of 0.5 seconds. Fraction of inspired oxygen (FiO2) will be adjusted to keep infant's oxygen saturations within previously established clinical parameters.
Study Intervention Procedure and Data Collection:
At initiation of intervention, and at time 30, 60, 90, and 120 minutes, heart rate (HR), respiratory rate (RR), tidal volume (TV), minute ventilation, FiO2, oxygen saturations, peak Edi and PIP will be recorded four times in a one minute period and the values average to minimize normal variation. Current NAVA settings, TCO2, and blood pressure (BP) will also be recorded. At 60 minutes of intervention if the TCO2 level has not decreased by 5 torr from baseline or has risen, the current NAVA level will be increased by 50%. At 90 minutes if the TCO2 level has not decreased by 5 torr from baseline or has risen; the NAVA level will be increased by 50% from the current level. At the completion of the study (120 minutes or pCO2 outside of established limits) the HR, RR, BP, TV, minute ventilation, FiO2, oxygen saturations, peak Edi and PIP will be recorded four times in a one minute period and the values average to minimize normal variation. A capillary blood gas will be obtained according to standard unit protocol with a warmed heel.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal NIV-NAVA | Experimental | Device: Nasal NIV-NAVAInfants will be transitioned from their current mode of ventilation to nasal NIV-NAVA. If patients are currently on nasal NIV-NAVA an increase in the NAVA level will be utilized for the intervention. |
Who may qualify
- Ages
- 7 days to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- birth weight less than 1,500 grams
- Clinical history of respiratory distress syndrome treated with surfactant
- Chronological age greater than or equal to seven days
- 48 hours post-extubation or greater
- Medically stable per primary medical team
Key exclusion criteria (2 listed)
- Severe congenital abnormalities
- Grade III or IV interventricular hemorrhage.
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 |
|---|---|---|
| Nasal NIV-NAVAAlso: noninvasive, neurally adjusted ventilatory assist, nasal pharyngealInfants will be placed on nasal NIV-NAVA. Patients initial NAVA level will be set to generate a peak inspiratory pressure that is 8 cm of water greater than their current peak end expiratory pressure. If the infants are on nasal NIV-NAVA at the time of study entry their NAVA level will be increased by 50% rounded up to the nearest 0.1 cm of water per microvolt. | Device | Nasal NIV-NAVA |
Primary outcome
Change in Partial Pressure of Carbon Dioxide on Capillary Blood Gas
Time frame: 2 hours
difference between pCO2 (mm Hg) on capillary blood gas obtained within 6 hours of study and immediately after 2 hour study period
1 secondary outcome
Change in Fraction of Inspired Oxygen
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19593246Breatnach C, Conlon NP, Stack M, Healy M, O'Hare BP. A prospective crossover comparison of neurally adjusted ventilatory assist and pressure-support ventilation in a pediatric and neonatal intensive care unit population. Pediatr Crit Care Med. 2010 Jan;11(1):7-11. doi: 10.1097/PCC.0b013e3181b0630f.
- Background: PubMed 22481227de la Oliva P, Schuffelmann C, Gomez-Zamora A, Villar J, Kacmarek RM. Asynchrony, neural drive, ventilatory variability and COMFORT: NAVA versus pressure support in pediatric patients. A non-randomized cross-over trial. Intensive Care Med. 2012 May;38(5):838-46. doi: 10.1007/s00134-012-2535-y. Epub 2012 Apr 6.
- Background: PubMed 21946913Clement KC, Thurman TL, Holt SJ, Heulitt MJ. Neurally triggered breaths reduce trigger delay and improve ventilator response times in ventilated infants with bronchiolitis. Intensive Care Med. 2011 Nov;37(11):1826-32. doi: 10.1007/s00134-011-2352-8. Epub 2011 Sep 23.
- Background: PubMed 21830318Alander M, Peltoniemi O, Pokka T, Kontiokari T. Comparison of pressure-, flow-, and NAVA-triggering in pediatric and neonatal ventilatory care. Pediatr Pulmonol. 2012 Jan;47(1):76-83. doi: 10.1002/ppul.21519. Epub 2011 Aug 9.
- Background: PubMed 22580718Bordessoule A, Emeriaud G, Morneau S, Jouvet P, Beck J. Neurally adjusted ventilatory assist improves patient-ventilator interaction in infants as compared with conventional ventilation. Pediatr Res. 2012 Aug;72(2):194-202. doi: 10.1038/pr.2012.64.
- Background: PubMed 19593241Bengtsson JA, Edberg KE. Neurally adjusted ventilatory assist in children: an observational study. Pediatr Crit Care Med. 2010 Mar;11(2):253-7. doi: 10.1097/PCC.0b013e3181b0655e.
- Background: PubMed 22658785Lee J, Kim HS, Sohn JA, Lee JA, Choi CW, Kim EK, Kim BI, Choi JH. Randomized crossover study of neurally adjusted ventilatory assist in preterm infants. J Pediatr. 2012 Nov;161(5):808-13. doi: 10.1016/j.jpeds.2012.04.040. Epub 2012 Jun 1.
- Background: PubMed 19242486Keszler M. State of the art in conventional mechanical ventilation. J Perinatol. 2009 Apr;29(4):262-75. doi: 10.1038/jp.2009.11. Epub 2009 Feb 26.
- Background: PubMed 22137670Stein H, Howard D. Neurally adjusted ventilatory assist in neonates weighing <1500 grams: a retrospective analysis. J Pediatr. 2012 May;160(5):786-9.e1. doi: 10.1016/j.jpeds.2011.10.014. Epub 2011 Dec 3.
- 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 19218884Beck J, Reilly M, Grasselli G, Mirabella L, Slutsky AS, Dunn MS, Sinderby C. Patient-ventilator interaction during neurally adjusted ventilatory assist in low birth weight infants. Pediatr Res. 2009 Jun;65(6):663-8. doi: 10.1203/PDR.0b013e31819e72ab.
- Background: PubMed 17960364Beck J, Brander L, Slutsky AS, Reilly MC, Dunn MS, Sinderby C. Non-invasive neurally adjusted ventilatory assist in rabbits with acute lung injury. Intensive Care Med. 2008 Feb;34(2):316-23. doi: 10.1007/s00134-007-0882-x. Epub 2007 Oct 25.
- Individual participant dataSharing planned: No
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.
Tarah T Colaizy, M.D., MPH principal investigator
University of Iowa
Gary J Kummet, M.D. study director
University of Iowa
Jonathan C Klein, M.D. study director
University of Iowa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal NIV-NAVA in people with Inadequate; Pulmonary Ventilation, Newborn and Infant, Very Low Birth Weight, run by Tarah T Colaizy at 2 sites 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 8 inclusion and 2 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 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 9 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Partial Pressure of Carbon Dioxide on Capillary Blood Gas (time frame: 2 hours). 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 NCT01785563, which also lists 16 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 9 Jun 2022.