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

A Pilot Study Comparing Infant Flow SiPAP to Noninvasive NAVA

When babies are born premature, they often need help with their breathing. The equipment used to help them breathe is not very comfortable and they sometimes need to be put on a specialized breathing machine with a tube into their lungs. The breathing machine or ventilator can be damaging to the newborn's lungs and more damage can occur the longer the newborn stays on a ventilator leading to chronic lung disease later in their lives. A new device called neurally adjusted ventilatory assist or NAVA is available that the investigators believe may be more comfortable for the premature newborn and may help the baby come off breathing support sooner. When using this device, babies may not need to be put on a ventilator and can avoid the lung damage associated with the breathing tube and the ventilator. The objective of this pilot study is to compare this new breathing device called NAVA, to the equipment that is currently being used, called SiPAP, to support premature newborn's breathing after birth without a breathing tube. The investigators hope to show that with this new technology, premature newborns that are having a difficult time breathing, will come off breathing support sooner compared to the breathing machines that are currently being used. The hypothesis for this proposed study is that improved synchrony with noninvasive NAVA will decrease time spent on noninvasive ventilation and avoid intubation.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Device: SiPAP - placebo; Device: Neurally Adjusted Ventilatory Assist (NAVA)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 1Z2
      • Surrey Memorial Hospital
    • Surrey, British Columbia, Canada, V3V1Z2
      • Surrey Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Infants born greater than or equal to 28+0 weeks and less than or equal to 31+6 weeks gestation
• Diagnosis of RDS in the first 24 hours of life requiring respiratory support
• Parental consent obtained

Exclusion Criteria:

• Infants with a major congenital anomaly
• Infants with pulmonary hypoplasia
• Infants known or suspected to have a neuromuscular disorder
• Infants less than 28+0 weeks GA
• Intubated infants that are likely to require continued mechanical ventilation
• Infants requiring vigorous resuscitation at birth, including chest compressions +/- cardiac medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: SiPAP	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.
Experimental: Neurally Adjusted Ventilatory Assist	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
total duration of respiratory support which includes both days and hours on NAVA/SiPAP (DORS)	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of infants that required escalation to increased noninvasive respiratory support (BiPhasic or increasing NAVA levels) or intubation and mechanical ventilation	one year
All cause mortality during the hospitalization	one year
Bronchopulmonary dysplasia defined as oxygen requirements or ventilatory support needs at 36 weeks CGA	one year
Number of doses of surfactant	one year
Incidence of pneumothorax	one year
Total duration of oxygen requirement	one year
Incidence of nasal deformities, specifically nasal erosions	one year
Time to reach full volume feeds (at least 120 ml/kg/day)	one year
Time to regain birth weight	one year
Total length of hospital stay	one year

Collaborators and Investigators

• Sponsor: Fraser Health
• Investigators: Principal Investigator: Ravinder Kajla, Fraser Health; Study Chair: Rebecca Sherlock, MD, Fraser Health

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: April 26, 2012
• First Submitted That Met QC Criteria: April 27, 2012
• First Posted (Estimate): April 30, 2012

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 25, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: NAVA