Recruiting

Video-based Visualization

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07426016

Conditions

Respiratory Distress Syndrome (Neonatal)

Surfactant Deficiency Syndrome Neonatal

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Video Laryngoscopy

Direct Laryngoscopy

Study Details

Brief 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?

Conditions

Respiratory Distress Syndrome (Neonatal)

Surfactant Deficiency Syndrome Neonatal

Study ID

NCT07426016

Start date

Jun 11, 2026

Status verified date

Jun, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Video Laryngoscopy

Video Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter

Direct Laryngoscopy

Direct Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter

Primary outcome measure

  • Rate of first attempt success [ Time Frame: During procedure ]

Central Contacts and Locations

Central contacts

Principal Investigator, MD

214-648-3383riti.chokshi@utsouthwestern.edu

Locations

Parkland Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

Office of Research Administration

214-645-8300irb@utsouthwestern.edu

Principal Investigator:

Riti Chokshi, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • less invasive surfactant
  • neonatal
  • video laryngoscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-06-15.