Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome
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|ClinicalTrials.gov Identifier: NCT01274845|
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : January 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Meconium Aspiration Syndrome||Other: Heliox mechanical ventilation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Other: 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.
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274845
|Department of Neonatology at Poznań University of Medical Sciences|
|Poznań, Poland, 60-535|
|Principal Investigator:||Tomasz Szczapa, MD, PhD||Department of Neonatology at Poznań University of Medical Sciences|