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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Respiratory Distress Syndrome Bronchopulmonary Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NCPAP + standard air

Group Type ACTIVE_COMPARATOR

NCPAP + standard air

Intervention Type OTHER

NCAP (SiPAP, Vyasis) was used to administer standard air

NCPAP + Heliox

Intervention Type OTHER

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.

NCPAP + Heliox

Group Type EXPERIMENTAL

NCPAP + standard air

Intervention Type OTHER

NCAP (SiPAP, Vyasis) was used to administer standard air

NCPAP + Heliox

Intervention Type OTHER

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.

Interventions

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NCPAP + standard air

NCAP (SiPAP, Vyasis) was used to administer standard air

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No