Status:
UNKNOWN
High Flow Nasal Cannula Versus Nasal Intermittent Positive Pressure (NIPPV) in Preterm Infants
Lead Sponsor:
Carmel Medical Center
Conditions:
Preterm Infant
Eligibility:
All Genders
Phase:
NA
Brief Summary
The aim of this study is to compare the effectiveness of Heated Humidified High Flow Nasal Cannula (HHHFNC) versus Nasal Intermittent Positive Pressure Ventilation (NIPPV) in preventing intubation whe...
Detailed Description
Patient population will include preterm infants born at 24 - 36+6 weeks of gestation who are candidates for non-invasive respiratory support post extubation or as primary respiratory support after bir...
Eligibility Criteria
Inclusion
- Infants born at 24-27+6 weeks of gestation and up to 28 days of life who are extubated for the first time after birth or immediately after surfactant administration via (intubation-surfactant-extubation) INSURE or (minimally invasive surfactant therapy) MIST procedures.
- Infants born at 28-36+6 weeks of gestation and up to 28 days of life who are candidates for non-invasive support either as a primary modality after birth or post extubation.
- Signed parental informed consent by one of the parents
Exclusion
- Infants who are unlikely to survive the immediate postnatal period or who have significant congenital abnormalities
- Presence of a pneumothorax prior to enrollment
- Hemodynamic instability due to sepsis or hemorrhage
- Inability to obtain parental consent
- Shortage of suitable equipment
- Infants who were intubated solely for surgery
Key Trial Info
Start Date :
January 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03853161
Start Date
January 21 2018
End Date
July 1 2023
Last Update
February 9 2021
Active Locations (1)
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1
Carmel Medical Center
Haifa, Israel