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

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome
• Interventions: Device: SiPAP - placebo; Device: Neurally Adjusted Ventilatory Assist (NAVA)

• Registration Number: NCT01588080
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Study Start: 2012-07
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-25
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SiPAP	SiPAP - placebo	-
Neurally Adjusted Ventilatory Assist	Neurally Adjusted Ventilatory Assist (NAVA)	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Surrey Memorial Hospital; 🇨🇦 Surrey, British Columbia, Canada