N/A
N=40
Nasal Noninvasive NAVA in the Very Low Birth Weight Infant
Inadequate; Pulmonary Ventilation, Newborn · Infant, Very Low Birth Weight
Bottom Line
View on ClinicalTrials.gov: NCT01785563 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Change in Partial Pressure of Carbon Dioxide on Capillary Blood Gas — 0.019 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nasal NIV-NAVA (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Tarah T Colaizy
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Partial Pressure of Carbon Dioxide on Capillary Blood Gas |
0.019 | — |
| SECONDARY Change in Fraction of Inspired Oxygen |
-0.012 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion criteria
- Severe congenital abnormalities
- Grade III or IV interventricular hemorrhage.
Data sourced from ClinicalTrials.gov (NCT01785563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.