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Clinical trialNCT02860325CompletedInterventional

NIV-NAVA Versus Nasal Continuous Positive Airway Pressure (nCPAP) or Non Synchronized NIPPV

SponsorComplejo Hospitalario Universitario Insular Materno InfantilEnrollment56Apnea of PrematurityRespiratory Distress Syndrome, Newborn
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Spain
  • Complejo Hospitalario Universitario Insular Materno Infantil

    Las Palmas de Gran Canaria, Las Palmas, Spain

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Aug 2016
Primary completion
30 Nov 2017
Completion
31 Dec 2017
Last update posted
20 Dec 2017
Registered enrollment
56
Registry id
NCT02860325

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.