nHFOV vs nCPAP: Effects on Gas Exchange for the Treatment of Neonates Recovering From RDS

Summary

The purpose of this study is to compare the effects of two different techniques of non-invasive ventilation (nCPAP and nHFOV) on gas exchange in preterm infants recovering from respiratory distress syndrome.

Conditions

• Respiratory Distress Syndrome
• Preterm Birth

Interventions

DEVICE

Medin-cno

Medin-cno is a noninvasive ventilator. With this device we can practice either nCPAP and nHFOV ventilation.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• Ospedali Riuniti di Foggia

  collaborator OTHER

• Vittore Buzzi Children's Hospital

  collaborator OTHER

• Vilnius University

  collaborator OTHER

• Hospital San Pietro Fatebenefratelli

  collaborator OTHER

• Ospedale F. Del Ponte, Varese

  collaborator UNKNOWN

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  collaborator OTHER

• Fondazione Poliambulanza Istituto Ospedaliero

  lead OTHER

Principal Investigators

• Roberto Bottino, Doctor · Fondazione Poliambulanza Istituto Ospedaliero

• Giovanni Vento, Doctor · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

• Gianfranco Maffei, Doctor · Ospedali Riuniti di Foggia

• Gianluca Lista, Doctor · Vittore Buzzi Children's Hospital

• Vladimiras Chijenas, Doctor · Vilnius University

• Arunas Liubsys, Doctor · Vilnius University

• Chiara Consigli, Doctor · Hospital San Pietro Fatebenefratelli

• Massimo Agosti, Doctor · Ospedale F. Del Ponte, Varese

• Mariarosa Colnaghi, Doctor · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

7 Days

Max Age

6 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2017-03-31

Completion

2017-05-31

Countries

• Italy
• Lithuania

Study Locations