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Purpose

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?

Conditions

Eligibility

Eligible Ages
Between 0 Hours and 3 Days
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Video Laryngoscopy 		A video laryngoscopy will be used to visualize the vocal cords and place the LISA catheter for surfactant administration
  • Procedure: Video Laryngoscopy
    Video Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter
Active Comparator
Direct Laryngoscopy 		Direct laryngoscopy (no camera) will be used to visualize the vocal cords and place the LISA catheter for surfactant administration
  • Procedure: Direct Laryngoscopy
    Direct Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter

Recruiting Locations

Parkland Hospital
Dallas, Texas 75235
Contact:
Office of Research Administration
214-645-8300
irb@utsouthwestern.edu

More Details

Status
Recruiting
Sponsor
University of Texas Southwestern Medical Center

Study Contact

Principal Investigator, MD
214-648-3383
riti.chokshi@utsouthwestern.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.