Status:
COMPLETED
LISA in the Delivery Room for Extremely Preterm Infants
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Chiesi USA, Inc.
Conditions:
Extreme Prematurity
Respiratory Distress Syndrome
Eligibility:
All Genders
5-20 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effect of LISA used in the delivery room (DR) in decreasing the intubation rates in preterm infants at 22-25 weeks gestational age (GA), during first 72 ho...
Detailed Description
This is a single center, unblinded, randomized control, feasibility trial to evaluate the use of LISA in the DR for extremely preterm infants born 22-25 weeks GA who were successfully resuscitated wit...
Eligibility Criteria
Inclusion
- Infants born 22 -25 weeks GA
- Resuscitated without requiring intubation and maintaining HR \>100, and spontaneous respiratory effort on CPAP 5-7 cm H2O)
Exclusion
- Major congenital anomalies
- Infants receiving only comfort care
- Mothers with impaired decision making capacity
Key Trial Info
Start Date :
June 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04715373
Start Date
June 22 2021
End Date
April 8 2025
Last Update
January 8 2026
Active Locations (1)
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1
Venkatakrishna Kakkilaya
Dallas, Texas, United States, 75093