Clinical trial NCT01877720: Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants
Official title: Physiologic Comparison Between Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) and Pressure Support (PS) in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants
Keywords: Preterm infant less than 32 weeks of gestation age
intubated more than 48 hours after birth
postextubation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Rotary
First posted: 2013-06-14
Enrollment: 16
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing, inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator assistance, and the asynchrony index (AI).


Eligibility criteria: Inclusion Criteria:

* preterm infants less than 32 weeks of gestational age
* intubated more than 48 hours after birth
* subjected to extubation with minimal ventilator setting (mean airway pressure \< 7cmH2O + peak inspiratory pressure \< 13 cmH2O + FiO2 \< 0.4 + respiratory rate \< 35/min)
* with informed consent from parents

Exclusion Criteria:

* with major congenital anomalies
* use of sedative or anesthetic drugs
* hemodynamic instability
* grade 3 or higher intraventricular hemorrhage
* phrenic nerve palsy

Primary outcomes:
measure: Trigger Delay
timeFrame: last 5-min of each 15-min trial
Secondary outcomes:
measure: Ti_excess (Inspiratory Time in Excess)
timeFrame: last 5-min of each 15-min trial
measure: Minute Ventilation Volume
timeFrame: last 5-min of each 15-min trial
measure: Peak Inspiratory Pressure
timeFrame: last 5-min of each 15-min trial
measure: Pneumatic Respiratory Rate
timeFrame: last 5-min of each 15-min trial
measure: Maximum EAdi
timeFrame: last 5-min of each 15-min trial
measure: Swing EAdi
timeFrame: last 5-min of each 15-min trial
measure: Leakage
timeFrame: last 5-min of each 15-min trial
measure: All Asynchrony Events
timeFrame: last 5-min of each 15-min trial
measure: Asynchrony Index
timeFrame: last 5-min of each 15-min trial
measure: SpO2
timeFrame: last 5-min of each 15-min trial
measure: Heart Rate
timeFrame: last 5-min of each 15-min trial
measure: Blood Pressure
timeFrame: last 5-min of each 15-min trial
measure: Respiratory Rate
timeFrame: last 5-min of each 15-min trial
Other outcomes:
Locations:
city: Bundang
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Han-Suk Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee J, Kim HS, Jung YH, Shin SH, Choi CW, Kim EK, Kim BI, Choi JH. Non-invasive neurally adjusted ventilatory assist in preterm infants: a randomised phase II crossover trial. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F507-13. doi: 10.1136/archdischild-2014-308057. Epub 2015 Jul 15.