Comparison Between Infant Flow SiPAP and Noninvasive NAVA in the Neonatal Intensive Care Unit

NACompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Respiratory Distress Syndrome
Interventions
DEVICE

Neurally Adjusted Ventilatory Assist (NAVA)

Neurally adjusted ventilatory assist (NAVA), an adjunct that can only be used with the Servo-i ventilator, allows the patient to synchronize spontaneous respiratory effort with mechanical ventilation. NAVA uses the electromyographic signal of the diaphragm (Edi) to transmit this electrical activity back to the ventilator. The NAVA catheter is a functional gastric tube that has electrodes embedded within it and positioned at the level of diaphragm using an electrocardiogram signal. These electrodes continuously (every 5ms) detect the amplitude, duration, and frequency of the Edi and provide pressure support in proportion to this electrical activity. Proportionality is controlled by a NAVA factor (cmH20/microvolt) and is adjusted by the user.

DEVICE

SiPAP - placebo

The Infant Flow® SiPAP provides noninvasive support to neonates. CPAP and Biphasic modes are provided by the Infant Flow® SiPAP. CPAP is an elevated pressure (above atmospheric) and is used to increase a premature babies functional residual capacity (FRC). CPAP is a modality used for babies with both central apneas and mild/moderate increase work of breathing. CPAP increases the FRC and ultimately recruits collapsed alveoli and improves gas exchange in the lungs. BiPhasic, on the other hand, is a modality used for babies that require more respiratory support than CPAP can provide. In BiPhasic mode, respiratory rate (RR), inspiratory time (Ti), and peak inspiratory pressures (PIP) are set and not synchronized with the patients breathing efforts.

Trial Locations (2)

V3V 1Z2

Surrey Memorial Hospital, Surrey

V3V1Z2

Surrey Memorial Hospital, Surrey

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Fraser Health

OTHER