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

Meconium Aspiration Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274845
• Other study ID #: 503-02-02215338-22961-03550
• Status: Completed
• Phase: N/A
• First received: January 10, 2011
• Last updated: January 11, 2011
• Start date: December 2006
• Est. completion date: December 2008

Study information

• Verified date: January 2011
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Day

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meconium Aspiration Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Neonatology at Poznan University of Medical Sciences	Poznan

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in acid-base balance and oxygenation	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.	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.	Yes
Secondary	Changes in respiratory parameters	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).	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.	Yes