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

Fraser Health

Status

Completed

Conditions

Respiratory Distress Syndrome

Treatments

Device: SiPAP - placebo

Device: Neurally Adjusted Ventilatory Assist (NAVA)

Study type

Interventional

Funder types

Other

Identifiers

NCT01588080

NAVA

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

28 to 32 weeks old

Volunteers

No Healthy Volunteers

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