Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome

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

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-12-31

Brief Summary

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The aim of the study: to assess the effect of short-term mechanical ventilation with heliox in newborns with meconium aspiration syndrome on vital signs, oxygenation, acid-base balance and respiratory function parameters.

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Detailed Description

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Conditions

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Meconium Aspiration Syndrome

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Heliox

Group Type OTHER

Heliox mechanical ventilation

Intervention Type OTHER

Mechanical ventilation (MV) with air-oxygen at baseline, then 1 hour of heliox (helium-oxygen) MV and then return to MV with air-oxygen.

Interventions

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Heliox mechanical ventilation

Mechanical ventilation (MV) with air-oxygen at baseline, then 1 hour of heliox (helium-oxygen) MV and then return to MV with air-oxygen.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* meconium aspiration syndrome diagnosed based on clinical and radiological findings,
* respiratory failure requiring mechanical ventilation

Exclusion Criteria

* congenital malformations or congenital genetic syndromes,
* persistent pulmonary hypertension of the newborn (PPHN) requiring inhaled nitric oxide treatment

Maximum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No