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HHHFNC (Heated Humidified High-Flow Nasal Cannula) Versus NCPAP for Respiratory Distress Syndrome of Prematurity

NCT02570217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2015-10-07

No results posted yet for this study

Summary

Preterm infants ranging from 29+0 to 36+6 weeks+days are randomly assigned to one of the following treatments as non invasive respiratory support if they develop mild to moderate Respiratory Distress Syndrome within 72 hrs from birth: 1) NCPAP set at 4-6 cmH2O or 2) HHHFNC providing a flow 4-6 l/min.

The aim of the study is to assess efficacy and safety of relative "new" form of respiratory support (HHHFNC) versus a more common one (NCPAP).

Conditions

  • Newborn Respiratory Distress Syndrome

Interventions

DEVICE

HHHFNC

infants receive non-invasive respiratory support by mean of HHHFNC

DEVICE

NCPAP

infants receive non-invasive respiratory support by mean of NCPAP

Sponsors & Collaborators

  • Dr Anna Lavizzari

    collaborator UNKNOWN

  • Dr Francesca Gaia Ciuffini

    collaborator UNKNOWN

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Mariarosa Colnaghi, MD · IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
29 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-06-30
Completion
2014-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02570217 on ClinicalTrials.gov