Impact of Synchronized Nasal Intermittent Positive Pressure Ventilation Using NAVA in Preterm Infants With RDS
Launched by HOSPITAL ISRAELITA ALBERT EINSTEIN · Jan 7, 2014
Trial Information
Current as of October 18, 2025
Unknown status
Keywords
ClinConnect Summary
Type and location of the study A prospective , randomized , open label clinical study will be conducted at the Albert Einstein Jewish Hospital Neonatal ICU, after approval by the Ethics Committee and the Research Institute of Education and Research. To participate in the study the parents or legal guardians must complete and sign the Statement of Consent.
Randomization and formation of study groups Two study groups will be formed according to the type of non- invasive ventilatory support: SNIPPV Group (synchronized nasal intermittent positive pressure) and CPAP group (continuous positive a...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Will be included in study preterm infants with respiratory failure and indication of noninvasive ventilatory support, characterized by clinical evidence of respiratory failure requiring use of oxygen greater than or equal to a FiO2 0.25.
- Exclusion Criteria:
- • Will be excluded from the study infants that parents did not agree on participation; diagnosed with major congenital anomalies; with necessity of chest drainage; diagnosis of intracranial hemorrhage grades III and IV according to the criteria of Papile et al; persistence ductus arteriosus with hemodynamic consequences and diagnosis of severe perinatal asphyxia - defined as less than 6 APGAR with 5 minutes of life.
About Hospital Israelita Albert Einstein
Hospital Israelita Albert Einstein is a leading healthcare institution in Brazil, renowned for its commitment to excellence in patient care, education, and research. As a prominent clinical trial sponsor, the hospital emphasizes innovation and scientific advancement, facilitating cutting-edge studies across various medical disciplines. With a state-of-the-art infrastructure and a dedicated team of professionals, Hospital Israelita Albert Einstein fosters collaboration with global research networks to enhance clinical outcomes and contribute to the advancement of medical knowledge. The institution is dedicated to adhering to the highest ethical standards and regulatory compliance, ensuring the safety and well-being of trial participants.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sao Paulo, Brazil
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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