NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS)

June 27, 2011 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Infants born between 28 and 32 weeks' gestation with radiological findings and clinical symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) within the first hour of life, were randomized to receive either standard medical air or a Heliox/Oxygen mixture 80/20 (Heliox) during the first 12 hours of life, followed by medical air until NCPAP was needed. The aim of the study was to assess the therapeutic effects of breathing a low-density gas mixture (heliox: 80% helium and 20% oxygen) in premature babies with Respiratory Distress Syndrome (RDS), undergoing NCPAP in terms of reducing the rate of mechanical ventilation (MV).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20122
        • NICU, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Università degli Studi di Milano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • inborn infants between 28 and 32 weeks of GA
  • Silverman score > 5,
  • radiological finding of RDS
  • a requirement of inspiratory flow of oxygen (FiO2) > 0,25 (SaO2 ) between 88-95% within the first hour of life.

Exclusion Criteria:

  • major congenital malformations
  • intraventricular hemorrhage (IVH) more than grade 2
  • need of intubation in the delivery room or requirement of FiO2 >0,4 during the first hour of life.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NCPAP + standard air
Other: NCPAP + standard air
NCAP (SiPAP, Vyasis) was used to administer standard air
Other: NCPAP + Heliox
Heliox21 (mixture of Helium 80%- Oxygen 20%) (BOC Medical UK- The Linde group) was stored in 10 liter cylinders and administrated through NCPAP for 12 hours (study period) starting from randomization.
Experimental: NCPAP + Heliox
Other: NCPAP + standard air
NCAP (SiPAP, Vyasis) was used to administer standard air
Other: NCPAP + Heliox
Heliox21 (mixture of Helium 80%- Oxygen 20%) (BOC Medical UK- The Linde group) was stored in 10 liter cylinders and administrated through NCPAP for 12 hours (study period) starting from randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy in reducing need of MV
Time Frame: 7 days
efficacy in reducing need of intubation for MV in infantans undergoing NCPAP within the first 7 days of life
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surfactant need
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
number of doses of exogenous surfactant
participants will be followed for the duration of hospital stay, an expected average of 10 weeks
major complications of prematurity
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
incidence of major complications of prematurity
participants will be followed for the duration of hospital stay, an expected average of 10 weeks
ventilatory assistance
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
number of days of ventilatory assistance
participants will be followed for the duration of hospital stay, an expected average of 10 weeks
length of stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
number of days of hospital stay
participants will be followed for the duration of hospital stay, an expected average of 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

March 9, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimate)

June 28, 2011

Study Record Updates

Last Update Posted (Estimate)

June 28, 2011

Last Update Submitted That Met QC Criteria

June 27, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Heliox

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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