CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
helioxdrug
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/NCT04404816
NCT04404816Phase 2Completed

Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome on Pulmonary Function and Electric Activity of the Diaphragm

Poznan University of Medical Sciences·interventional·Posted May 28, 2020·Updated Jun 9, 2020

In Brief

A Phase 2 clinical trial evaluating heliox for Respiratory Distress Syndrome and Premature Infants. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The use of a mixture of helium with oxygen (heliox) as a breathing gas may be beneficial due to its unique physical properties, such as low density and high carbon dioxide (CO2) diffusion coefficient. In previous studies in neonates with respiratory failure, conventional ventilation with heliox was associated with improved oxygenation and selected respiratory parameters. The use of heliox may increase the effectiveness of intermittent nasal positive pressure ventilation (NIPPV), but knowledge about the effects of such therapy on newborns is limited.The use of non- invasive neurally adjusted ventilatory assist (NIV-NAVA) allows synchronization and assessment of electrical activity of the diaphragm (EaDI) during heliox administration in premature babies with respiratory failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPoland

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 28, 2020
Enrollment StartJan 1, 2017
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.1 years ago

Interventions

helioxdrug

NIV-NAVA with a conventional gas mixture (air-oxygen) at baseline, 3 hours of NIV-NAVA with heliox and return to NIV-NAVA with air-oxygen.