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

Not Applicable

Completed

• Conditions: Meconium Aspiration Syndrome

• Registration Number: NCT01274845
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2011-01
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-11
• Last Update Submitted: 2011-01-11
• Study First Posted: 2011-01-12
• Last Update Posted: 2011-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes in acid-base balance and oxygenation	Parameters recorded first at the baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation.	Acid-base balance and oxygenation assessed on arterial blood gas samples, saturation measured with a pulse oximeter and calculated values of oxygenation index and alveolar-arterial oxygen tension difference.

Secondary Outcome Measures

Name	Time	Method
Changes in respiratory parameters	Parameters recorded first at baseline during ventilation with air-oxygen gas mixture, then after 15 and 60 minutes of the heliox ventilation and finally 15 and 60 minutes after switching back to air-oxygen ventilation.	Analyzed parameters: tidal volume (VT, \[ml/kg\]), minute ventilation (VE, \[l\]) and peak expiratory flow rate (PEFR, \[l/min\]). Recorded ventilator settings: respiratory rate (RR), mean airway pressure (MAP) and fraction of inspired oxygen (FiO2).

Trial Locations

Locations (1)

Department of Neonatology at Poznań University of Medical Sciences; 🇵🇱 Poznań, Poland