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

Respiratory Distress Syndrome Clinical Trial

Official title:

A Pilot Study Comparing Infant Flow SiPAP to Noninvasive NAVA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588080
• Other study ID #: NAVA
• Status: Completed
• Phase: N/A
• First received: April 26, 2012
• Last updated: May 25, 2015
• Start date: July 2012
• Est. completion date: November 2014

Study information

• Verified date: May 2015
• Source: Fraser Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Weeks to 32 Weeks

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Surrey Memorial Hospital	Surrey	British Columbia
Canada	Surrey Memorial Hospital	Surrey	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Fraser Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total duration of respiratory support which includes both days and hours on NAVA/SiPAP (DORS)		one year	No
Secondary	Proportion of infants that required escalation to increased noninvasive respiratory support (BiPhasic or increasing NAVA levels) or intubation and mechanical ventilation		one year	No
Secondary	All cause mortality during the hospitalization		one year	No
Secondary	Bronchopulmonary dysplasia defined as oxygen requirements or ventilatory support needs at 36 weeks CGA		one year	No
Secondary	Number of doses of surfactant		one year	No
Secondary	Incidence of pneumothorax		one year	No
Secondary	Total duration of oxygen requirement		one year	No
Secondary	Incidence of nasal deformities, specifically nasal erosions		one year	No
Secondary	Time to reach full volume feeds (at least 120 ml/kg/day)		one year	No
Secondary	Time to regain birth weight		one year	No
Secondary	Total length of hospital stay		one year	No