Trial record 1 of 13 for:    "Meconium aspiration syndrome"
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Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome

This study has been completed.
Sponsor:
Information provided by:
Poznan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01274845
First received: January 10, 2011
Last updated: January 11, 2011
Last verified: January 2011
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   up to 1 Day
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 10, 2011
Last Updated: January 11, 2011
Health Authority: Poland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014