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Randomized Controlled Trial of Video-Laryngoscopy Intervention or Direct Laryngoscopy for Delivery of Less Invasive Surfactant Administration for Premature Infants

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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?

Eligibility
Participation Requirements
Sex: All
Maximum Age: 3 days
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
Parkland Hospital
RECRUITING
Dallas
Contact Information
Primary
Principal Investigator, MD
riti.chokshi@utsouthwestern.edu
214-648-3383
Time Frame
Start Date: 2026-06-11
Estimated Completion Date: 2028-11
Participants
Target number of participants: 100
Treatments
Active_comparator: Video Laryngoscopy
A video laryngoscopy will be used to visualize the vocal cords and place the LISA catheter for surfactant administration
Active_comparator: Direct Laryngoscopy
Direct laryngoscopy (no camera) will be used to visualize the vocal cords and place the LISA catheter for surfactant administration
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov