Status:
UNKNOWN
Comparison of Efficacy of Less Invasive Surfactant Treatment Under Nasal CPAP and Nasal IPPV
Lead Sponsor:
Uludag University
Conditions:
Respiratory Distress Syndrome
Eligibility:
All Genders
24-29 years
Phase:
NA
Brief Summary
Non invasive ventilation is important in the care of preterm infants with respiratory failure, and surfactant treatment can be use with non invasive ventilation. However, there is no consensus on the ...
Detailed Description
This CURLISPAP study was a multicenter, randomized controlled study at six level III neonatal intensive care units (NICUs) in Turkey. The protocol was approved by the ethics committee of each particip...
Eligibility Criteria
Inclusion
- Gestational age 24 -29 week
- Clinical and radiological diagnosis of RDS
- Born in a hospital with a study center
- Spontaneous breathing
- Within the first 6 hours
- Non-invasive ventilation and FiO2 requirement \>0.30
- Parental concent
Exclusion
- Major congenital malformations
- Need of mechanical ventiation
- Need of entubation in delivery room
- Air weak syndrome
- No parental concent
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04698473
Start Date
December 1 2020
End Date
December 1 2022
Last Update
January 22 2021
Active Locations (1)
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1
Hilal Ozkan
Bursa, Select..., Turkey (Türkiye), 16285