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

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.

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Key information

Conditions

Meconium Aspiration Syndrome Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Infant, Newborn, Diseases Lung Diseases Lung Injury Pregnancy Complications Respiration Disorders Respiratory Tract Diseases Urogenital Diseases

Age range

Up to 1 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neonatology at Poznań University of Medical Sciences

Poznan, 60-535, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heliox mechanical ventilation

Other

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 outcomes

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 outcomes

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).

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jan 12, 2011
Registry last updated: Jan 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed