Clinical trial NCT01588080: Comparison Between Infant Flow SiPAP and Noninvasive NAVA in the Neonatal Intensive Care Unit
Official title: A Pilot Study Comparing Infant Flow SiPAP to Noninvasive NAVA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Lead sponsor: Fraser Health
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 21
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: total duration of respiratory support which includes both days and hours on NAVA/SiPAP (DORS)
timeFrame: one year
Secondary outcomes:
measure: Proportion of infants that required escalation to increased noninvasive respiratory support (BiPhasic or increasing NAVA levels) or intubation and mechanical ventilation
timeFrame: one year
measure: All cause mortality during the hospitalization
timeFrame: one year
measure: Bronchopulmonary dysplasia defined as oxygen requirements or ventilatory support needs at 36 weeks CGA
timeFrame: one year
measure: Number of doses of surfactant
timeFrame: one year
measure: Incidence of pneumothorax
timeFrame: one year
measure: Total duration of oxygen requirement
timeFrame: one year
measure: Incidence of nasal deformities, specifically nasal erosions
timeFrame: one year
measure: Time to reach full volume feeds (at least 120 ml/kg/day)
timeFrame: one year
measure: Time to regain birth weight
timeFrame: one year
measure: Total length of hospital stay
timeFrame: one year
Other outcomes:
Locations:
city: Surrey
country: Canada
facility: Surrey Memorial Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Surrey Memorial Hospital
state: British Columbia
Study officials:
affiliation: Fraser Health
name: Ravinder Kajla
role: PRINCIPAL_INVESTIGATOR
affiliation: Fraser Health
name: Rebecca Sherlock, MD
role: STUDY_CHAIR
References: