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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01274845
First Posted: January 12, 2011
Last Update Posted: January 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Poznan University of Medical Sciences
  Purpose
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.

Condition Intervention
Meconium Aspiration Syndrome Other: Heliox mechanical ventilation

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome

Resource links provided by NLM:


Further study details as provided by Poznan University of Medical Sciences:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 8
Study Start Date: December 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Heliox 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Poland
Department of Neonatology at Poznań University of Medical Sciences
Poznań, Poland, 60-535
Sponsors and Collaborators
Poznan University of Medical Sciences
Investigators
Principal Investigator: Tomasz Szczapa, MD, PhD Department of Neonatology at Poznań University of Medical Sciences
  More Information

Responsible Party: Tomasz Szczapa, Department of Neonatology at Poznań University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01274845     History of Changes
Other Study ID Numbers: 503-02-02215338-22961-03550
First Submitted: January 10, 2011
First Posted: January 12, 2011
Last Update Posted: January 12, 2011
Last Verified: January 2011

Keywords provided by Poznan University of Medical Sciences:
Meconium aspiration syndrome
Heliox
Mechanical ventilation
Newborn

Additional relevant MeSH terms:
Meconium Aspiration Syndrome
Syndrome
Disease
Pathologic Processes
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Fetal Diseases
Pregnancy Complications
Infant, Newborn, Diseases