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

• Sponsor: Poznan University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01274845
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meconium Aspiration Syndrome	Other: Heliox mechanical ventilation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of Heliox in the Management of Neonates With Meconium Aspiration Syndrome
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 1 Day
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01274845
• Other Study ID Numbers: 503-02-02215338-22961-03550
• First Posted: Jan 12, 2011
• Last Update Posted: Jan 12, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: Meconium aspiration syndrome; Heliox; Mechanical ventilation; Newborn
• Additional relevant MeSH terms: Meconium Aspiration Syndrome; Syndrome

Study Results

No Results Posted as of Jan 12, 2011