Nasal Noninvasive NAVA in the Very Low Birth Weight Infant
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|ClinicalTrials.gov Identifier: NCT01785563|
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : April 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Inadequate; Pulmonary Ventilation, Newborn Infant, Very Low Birth Weight||Device: Nasal NIV-NAVA||Not Applicable|
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, 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 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).
Infants will be maintained on previous level of PEEP 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nasal Noninvasive NAVA Provides Ventilation in the Very Low Birth Weight Infant|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
Experimental: Nasal NIV-NAVA
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.
Device: Nasal NIV-NAVA
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.
- Decrease in partial pressure of carbon dioxide on capillary blood gas [ Time Frame: 2 hours ]
- Decrease in fraction of inspired oxygen [ Time Frame: 2 hours ]
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): NCT01785563
|United States, Iowa|
|Children's Hospital of Iowa NICU|
|Iowa City, Iowa, United States, 52242|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Tarah T Colaizy, M.D., MPH||University of Iowa|
|Study Director:||Gary J Kummet, M.D.||University of Iowa|
|Study Director:||Jonathan C Klein, M.D.||University of Iowa|