Many preterm babies born between 22-28+6 weeks' estimated gestational age (EGA) need surfactant, a medicine that helps the lungs. The goal of the study is to compare the use of video-based visualization to direct visualization during a procedure called less invasive surfactant administration (LISA). The main questions the study aims to answer are: 1) does one method of visualization have a increased rate of giving the medicine successfully on the first attempt? 2) what benefits are there of each method?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Video Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter
Direct Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter
Parkland Hospital
Dallas, Texas, United States
RECRUITINGRate of first attempt success
Time frame: During procedure
Duration of desaturation below 80% SpO2 (sec),
Time frame: during procedure
Duration of bradycardia (HR <100 bpm)
Time frame: procedure duration
Number of desaturation/bradycardia episodes
Time frame: during procedure
Number of surfactant installation attempts
Time frame: during procedure
Time to completion of surfactant installation
Time frame: during procedure
Time to insertion of thin catheter
Time frame: during procedure
Amount of surfactant in stomach at the end of the procedure
Time frame: within 5 min after procedure
Mean maximum fractioned inspired O2 used
Time frame: during procedure
Lowest oxygen saturation during catheter insertion
Time frame: during procedure
Fractionated inspired oxygen (FiO2) at 60 mins post procedure
Time frame: 60 minutes post-procedure
Lowest heart rate during catheter insertion
Time frame: during procedure
Cross over to alternative method
Time frame: during procedure
Incidence of intubation at 72 hours post surfactant administration
Time frame: procedure to 72 hours post-procedure
Incidence of pneumothorax
Time frame: procedure to 72 hours post-procedure
Incidence of severe (grade III/IV) intraventricular hemorrhage
Time frame: Birth to discharge
Continuous Positive Expiratory Pressure (CPAP) at 60 mins post procedure
Time frame: 60 minutes post-procedure
Intubation during procedure
Time frame: During Procedure
Change in provider during procedure
Time frame: during procedure
Survival to discharge or 90 days
Time frame: up to 90 days
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