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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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In the past many neonates with respiratory distress syndrome would require intubation, but over the years these rates have declined as the capabilities of non-invasive ventilation (NIV) have vastly improved. Despite these improvements, the decrease in pressure transmission due to factors such as resistance from tubing or air leaks around the nostrils and mouth, continues to be one of the major drawbacks when using nasal NIV. Current ventilators measure the set pressures at the circuit but do not capture the delivered pressure at the patient's nares. Recently, Medtronic PB980 ventilators feature NIV plus and leak sync software that can be calibrated to measure the pressures provided at the nostrils. Optimum pressures received at the nostrils to provide safe and effective therapy in neonates is currently unknown. In the prospective portion of the study, we aim to evaluate safety and efficacy of the software by comparing the average pressure difference between the circuit and delivery pressure at the nares, the incidence of apnea, bradycardia, desaturations as well as escalation and de-escalation of ventilator support in newborns who are receiving NIV admitted to NICU
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infants receiving non invasive ventilation without NIV plus | No Intervention | ||
| Infants receiving non invasive ventilation with NIV plus | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIV plus software | Device | interventions received by infants studied after placing them on ventilator using NIV plus software |
|
| Measure | Description | Time Frame |
|---|---|---|
| interventions performed while using NIV plus software | will study the number of interventions performed when NIV plus software is used | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| difference in pressures set and received | will study the pressure difference as calculated by NIV plus software | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manoj Biniwale | Contact | 3234093406 | Biniwale@usc.edu | |
| Rangasamy Ramanathan | Contact | 3234093406 | Ramanath@usc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles General Medical Center | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |