Trial intelligence / Profile preview

Heliox NIV in Premature Infants with RDS

NCT04404816Phase 2

Key facts

Status: Completed
Start: Jan 2017
Primary completion: Dec 2018
Countries: 1
Sponsor: Poznan University of Medical Sciences
Modality: GAS (Genetic analysis systems)

Drugs: heliox
Conditions: respiratory distress syndrome (RDS)

Overview

Phase 2, open-label trial of heliox in respiratory distress syndrome (RDS) (2 arms), sponsored by Poznan University of Medical Sciences. Primary endpoints: Minimal Electrical Activity of the Diaphragm, Mean Electrical Activity of the Diaphragm and 5 more. Started Jan 2017; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Early NIV
Premature infants < 33 weeks GA requiring NIV in first 72h
Post-extubation NIV
Premature infants < 33 weeks GA requiring NIV after failed extubation

Who it enrols

Premature infants < 33 weeks GA with RDS requiring NIV (Group 1: early rescue; Group 2: post-extubation failure). Excludes major congenital anomalies and deteriorating pulmonary function (pH < 7.22, pCO2 > 65).

Endpoints

Primary

Minimal Electrical Activity of the Diaphragm180 min (Standard)
Mean Electrical Activity of the Diaphragm180 min (Standard)
Maximal Electrical Activity of the Diaphragm180 min (Standard)
Peak Inspiratory Pressure180 min (Standard)
Positive End-Expiratory Pressure180 min (Standard)

Secondary

Cerebral Tissue Oxygenation180 min (Standard)
Fraction of Inspired Oxygen180 min (Standard)
Capillary Blood Gas Analysis3 hours (Standard)
Heart Rate180 min (Standard)
Oxygen Saturation180 min (Standard)

Beyond the preview

Go deeper on NCT04404816.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT04404816.