Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The use of a mixture of helium with oxygen (heliox) as a breathing gas may be beneficial due to its unique physical properties, such as low density and high carbon dioxide (CO2) diffusion coefficient. In previous studies in neonates with respiratory failure, conventional ventilation with heliox was associated with improved oxygenation and selected respiratory parameters. The use of heliox may increase the effectiveness of intermittent nasal positive pressure ventilation (NIPPV), but knowledge about the effects of such therapy on newborns is limited.The use of non- invasive neurally adjusted ventilatory assist (NIV-NAVA) allows synchronization and assessment of electrical activity of the diaphragm (EaDI) during heliox administration in premature babies with respiratory failure.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poznan University of Medical Sciences
• Collaborator: European Society for Paediatric Research

Criteria

Inclusion Criteria (Group 1):

• GA under 33 weeks GA

• Need for NIV due to clinical symptoms of respiratory distress in course of RDS

• FiO2=0.25-0.4

• Enrollment within first 72 hours of life

• Parental consent

Inclusion Criteria (Group 2):

• GA under 33 weeks GA

• Need for MV due to clinical symptoms of respiratory distress

• at least one failed attempted extubation

• Parental consent

Exclusion Criteria:

• Major congenital anomalies

• Deteriorating pulmonary function despite NIV and the need for intubation and conventional mechanical ventilation (CMV) (Preliminary criteria: pH< 7.22, carbon dioxide partial pressure (pCO2) >65)