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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01274845

Enrollment

Registered

2011-01-12

Start date

2006-12-31

Completion date

2008-12-31

Last updated

2011-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meconium Aspiration Syndrome

Keywords

Meconium aspiration syndrome, Heliox, Mechanical ventilation, Newborn

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.

Interventions

OTHERHeliox 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.

Study design

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in acid-base balance and oxygenation	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

Measure	Time frame	Description
Changes in respiratory parameters	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).

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026