CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
NIV-NAVA +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02860325
NCT02860325N/ACompleted

Non-invasive Neurally Adjusted Ventilatory Assist Versus nCPAP or Non Synchronized NIPPV in Preterm Infants Under 32 Weeks Gestational Age: A Randomized Clinical Trial

Complejo Hospitalario Universitario Insular Materno Infantil·interventional·Posted Aug 9, 2016·Updated Dec 20, 2017

In Brief

A clinical study evaluating NIV-NAVA and Conventional for Respiratory Distress Syndrome, Newborn and Apnea of Prematurity. Completed, enrolled 56 participants across 1 site.

Detailed Summary

Mechanical respiratory support of preterm neonates with respiratory distress syndrome (RDS) and/or apnoea of prematurity (AOP) might be associated with adverse effects due to positive pressure (barotrauma), excessive gas delivery (volutrauma) or inadequate volume (atelectrauma). Asynchrony between patient efforts and ventilator support increases patient discomfort, favouring "fighting" the machine, and increases the risk of air trapping and lung overdistension even in patients with non-invasive ventilation (NIV). Recently, a new modality of synchronization has been available for pediatric and neonatal use: the neurally adjusted ventilatory assist (NAVA), which uses the diaphragmatic electrical activity (Edi) as a signal to start the rise in pressure of the ventilator, and to adjust the tidal volume and the inspiratory time (cycling off) to the patient needs, breath by breath. The aims of this study are to know whether NIV-NAVA compared to unsynchronized modalities (nCPAP/nIPPV), in infants born \< 32 weeks GA with respiratory distress syndrome or requiring prophylactic NIV (immaturity, apnoea) reduces systemic inflammation, measured by serum cytokines concentration, reduces the need for oxygen and respiratory support, and if it increases the probabilities of survival without bronchopulmonary dysplasia (BPD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 9, 2016
Enrollment StartAug 1, 2016
Primary CompletionNov 30, 2017
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.9 years ago

Interventions

NIV-NAVAdevice

Non-invasive ventilatory support by means of neurally adjusted ventilatory assist (SERVO-n, Maquet, Solna, Sweden)

Conventionaldevice

Non-invasive ventilatory support by means of nCPAP or non-synchronized nIPPV (Infant Flow, CareFusion)