Parkland Hospital
Dallas, Texas, 75235, United States
Location status: Recruiting
Location contact
Office of Research Administration
CONTACT
Riti Chokshi, MD
PRINCIPAL_INVESTIGATOR
Shalini Ramachandram, MD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT07426016
Video vs. Direct Laryngoscopy for Less Invasive Surfactant Administration
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?
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
0 hour–3 day
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Infants born ≤28 weeks GA successfully resuscitated in the delivery room (DR) and maintained on CPAP • Need for surfactant in the first 36 hours of life based on clinical assessment and/or meeting threshold per unit protocol
Exclusion criteria
- Infants born ≥29 weeks GA or
- Infants with known congenital anomalies or
- Infants who are determined by the primary care team to receive comfort care only or
- Infants who are intubated at any time prior to surfactant administration
Treatment and study plan
Video Laryngoscopy
ProcedureVideo Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter
Direct Laryngoscopy
ProcedureDirect Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter
Primary outcomes
-
Rate of first attempt success
Time frame: During procedure
Secondary outcomes
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Texas Southwestern Medical Center
Other
Registry information
Official study title
Randomized Controlled Trial of Video-Laryngoscopy Intervention or Direct Laryngoscopy for Delivery of Less Invasive Surfactant Administration for Premature Infants
Acronym: VID LISA
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2028
- First posted
- Feb 23, 2026
- Registry last updated
- Jun 15, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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