Clinical Trial: Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome

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 Summary:
Sponsor: Poznan University of Medical Sciences

Current Primary Outcome: Changes in acid-base balance and oxygenation [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in respiratory parameters [ Time Frame: 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).


Original Secondary Outcome: Same as current

Information By: Poznan University of Medical Sciences

Dates:
Date Received: January 10, 2011
Date Started: December 2006
Date Completion:
Last Updated: January 11, 2011
Last Verified: January 2011