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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01588080
Recruitment Status : Completed
First Posted : April 30, 2012
Last Update Posted : May 27, 2015
Information provided by (Responsible Party):
Ravinder Kajla, Fraser Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Device: Neurally Adjusted Ventilatory Assist (NAVA) Device: SiPAP - placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Comparing Infant Flow SiPAP to Noninvasive NAVA
Study Start Date : July 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

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.

Primary Outcome Measures :
  1. total duration of respiratory support which includes both days and hours on NAVA/SiPAP (DORS) [ Time Frame: one year ]

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

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Ages Eligible for Study:   28 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01588080

Canada, British Columbia
Surrey Memorial Hospital
Surrey, British Columbia, Canada, V3V 1Z2
Surrey Memorial Hospital
Surrey, British Columbia, Canada, V3V1Z2
Sponsors and Collaborators
Fraser Health
Principal Investigator: Ravinder Kajla Fraser Health
Study Chair: Rebecca Sherlock, MD Fraser Health

Responsible Party: Ravinder Kajla, Respiratory Therapist, Clinical Resource Therapist, Fraser Health Identifier: NCT01588080     History of Changes
Other Study ID Numbers: NAVA
First Posted: April 30, 2012    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases