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

This study is currently recruiting participants.
Verified March 2014 by Fraser Health
Sponsor:
Information provided by (Responsible Party):
Ravinder Kajla, Fraser Health
ClinicalTrials.gov Identifier:
NCT01588080
First received: April 26, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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 Intervention
Respiratory Distress Syndrome
Device: Neurally Adjusted Ventilatory Assist (NAVA)
Device: SiPAP - placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Comparing Infant Flow SiPAP to Noninvasive NAVA

Resource links provided by NLM:


Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • total duration of respiratory support which includes both days and hours on NAVA/SiPAP (DORS) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • All cause mortality during the hospitalization [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Bronchopulmonary dysplasia defined as oxygen requirements or ventilatory support needs at 36 weeks CGA [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Number of doses of surfactant [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Incidence of pneumothorax [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Total duration of oxygen requirement [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Incidence of nasal deformities, specifically nasal erosions [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Time to reach full volume feeds (at least 120 ml/kg/day) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Time to regain birth weight [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Total length of hospital stay [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   28 Weeks to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588080

Contacts
Contact: Rebecca Sherlock, MD (604) 839-7345 rsherlock73@gmail.com

Locations
Canada, British Columbia
Surrey Memorial Hospital Recruiting
Surrey, British Columbia, Canada, V3V1Z2
Contact: Rebecca Sherlock, MD    (604) 839-7345    rsherlock73@gmail.com   
Principal Investigator: Ravinder Kajla         
Sub-Investigator: Rebecca Sherlock, MD         
Surrey Memorial Hospital Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: Rebecca Sherlock, MD    (604) 839-7345    rsherlock73@gmail.com   
Sponsors and Collaborators
Fraser Health
Investigators
Principal Investigator: Ravinder Kajla Fraser Health
Study Chair: Rebecca Sherlock, MD Fraser Health
  More Information

No publications provided

Responsible Party: Ravinder Kajla, Respiratory Therapist, Clinical Resource Therapist, Fraser Health
ClinicalTrials.gov Identifier: NCT01588080     History of Changes
Other Study ID Numbers: NAVA
Study First Received: April 26, 2012
Last Updated: March 3, 2014
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on April 16, 2014