Status:
COMPLETED
Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome
Lead Sponsor:
Poznan University of Medical Sciences
Collaborating Sponsors:
European Society for Paediatric Research
Conditions:
Respiratory Distress Syndrome
Premature Infants
Eligibility:
All Genders
1+ years
Phase:
PHASE1
PHASE2
Brief 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....
Detailed Description
Aim of the study was to assess of the impact of non-invasive ventilation with heliox on respiratory function, diaphragm bioelectrical activity, cerebral oxygenation and selected vital signs in prematu...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04404816
Start Date
January 1 2017
End Date
December 1 2018
Last Update
June 9 2020
Active Locations (1)
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1
Gynecological and obstetric teaching hospital, Departament of Neonatology, Polna street 33
Poznan, Great Poland, Poland, 60-535