Trial record 1 of 13 for:    "Meconium aspiration syndrome"
Previous Study | Return to List | Next Study

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
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
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Fetal Diseases
Pregnancy Complications
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on April 21, 2014