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

NCT01383850 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2011-06-28

No results posted yet for this study

Summary

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).

Conditions

  • Respiratory Distress Syndrome
  • Bronchopulmonary Dysplasia

Interventions

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.

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-09-30
Completion
2010-09-30

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 NCT01383850 on ClinicalTrials.gov