Back to resultsUse of Heliox in the Management of Neonates With Meconium Aspiration Syndrome
Primary Purpose
Meconium Aspiration Syndrome
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Heliox mechanical ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Meconium Aspiration Syndrome focused on measuring Meconium aspiration syndrome, Heliox, Mechanical ventilation, Newborn
Eligibility Criteria
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
Sites / Locations
- Department of Neonatology at Poznań University of Medical Sciences
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Heliox
Arm Description
Outcomes
Primary Outcome Measures
Changes in acid-base balance and oxygenation
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
Changes in respiratory parameters
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).
Full Information
NCT ID
NCT01274845
First Posted
January 10, 2011
Last Updated
January 11, 2011
Sponsor
Poznan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01274845
Brief Title
Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome
Official Title
Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Poznan University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meconium Aspiration Syndrome
Keywords
Meconium aspiration syndrome, Heliox, Mechanical ventilation, Newborn
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heliox
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Heliox mechanical ventilation
Intervention Description
Mechanical ventilation (MV) with air-oxygen at baseline, then 1 hour of heliox (helium-oxygen) MV and then return to MV with air-oxygen.
Primary Outcome Measure Information:
Title
Changes in acid-base balance and oxygenation
Description
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.
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.
Secondary Outcome Measure Information:
Title
Changes in respiratory parameters
Description
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).
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.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Day
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Szczapa, MD, PhD
Organizational Affiliation
Department of Neonatology at Poznań University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neonatology at Poznań University of Medical Sciences
City
Poznań
ZIP/Postal Code
60-535
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome
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