Apnea of Newborn, Respiratory Distress Syndrome, Newborn
Conditions
Brief summary
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
Interventions
DEVICENIV plus software
interventions received by infants studied after placing them on ventilator using NIV plus software
Sponsors
Medtronic
Keck School of Medicine of USC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 30 Days
Healthy volunteers
No
Inclusion criteria
* Gestation Age of 23-41 weeks * Born at LAC+USC Medical Center and admitted to NICU * Received NIPPV or nasal CPAP
Exclusion criteria
* Infants with any congenital anomalies * Infants receiving only comfort care measures. * Infants receiving invasive mode of mechanical ventilation (intubated) * Non-inborn neonates * Re-admissions to the NICU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| interventions performed while using NIV plus software | 24 hours | will study the number of interventions performed when NIV plus software is used |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| difference in pressures set and received | 12 hours | will study the pressure difference as calculated by NIV plus software |
Countries
United States
Contacts
Primary ContactManoj Biniwale
Backup ContactRangasamy Ramanathan
Outcome results
None listed