Video vs. Direct Laryngoscopy for Less Invasive Surfactant Administration (VID LISA)

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

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 Overview

• Status: Not yet recruiting
• Conditions: Surfactant Deficiency Syndrome Neonatal; Respiratory Distress Syndrome (Neonatal)
• Intervention / Treatment: Procedure: Video Laryngoscopy; Procedure: Direct Laryngoscopy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Principal Investigator, MD; Phone Number: 214-648-3383; Email: riti.chokshi@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Parkland Hospital
      • Contact: Office of Research Administration; Phone Number: 214-645-8300; Email: irb@utsouthwestern.edu
      • Principal Investigator: Riti Chokshi, MD
      • Principal Investigator: Shalini Ramachandram, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of first attempt success	During procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of desaturation below 80% SpO2 (sec),	during procedure
Duration of bradycardia (HR <100 bpm)	procedure duration
Number of desaturation/bradycardia episodes	during procedure
Number of surfactant installation attempts	during procedure
Time to completion of surfactant installation	during procedure
Time to insertion of thin catheter	during procedure
Amount of surfactant in stomach at the end of the procedure	within 5 min after procedure
Mean maximum fractioned inspired O2 used	during procedure
Lowest oxygen saturation during catheter insertion	during procedure
Fractionated inspired oxygen (FiO2) at 60 mins post procedure	60 minutes post-procedure
Lowest heart rate during catheter insertion	during procedure
Cross over to alternative method	during procedure
Incidence of intubation at 72 hours post surfactant administration	procedure to 72 hours post-procedure
Incidence of pneumothorax	procedure to 72 hours post-procedure
Incidence of severe (grade III/IV) intraventricular hemorrhage	Birth to discharge
Continuous Positive Expiratory Pressure (CPAP) at 60 mins post procedure	60 minutes post-procedure
Intubation during procedure	During Procedure
Change in provider during procedure	during procedure
Survival to discharge or 90 days	up to 90 days

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Chokshi, MD, UT Southwestern; Principal Investigator: Shalini Ramachandran, MD, UT Southwestern

Publications and helpful links

General Publications

• Garcia-Marcinkiewicz AG, Kovatsis PG, Hunyady AI, Olomu PN, Zhang B, Sathyamoorthy M, Gonzalez A, Kanmanthreddy S, Galvez JA, Franz AM, Peyton J, Park R, Kiss EE, Sommerfield D, Griffis H, Nishisaki A, von Ungern-Sternberg BS, Nadkarni VM, McGowan FX Jr, Fiadjoe JE; PeDI Collaborative investigators. First-attempt success rate of video laryngoscopy in small infants (VISI): a multicentre, randomised controlled trial. Lancet. 2020 Dec 12;396(10266):1905-1913. doi: 10.1016/S0140-6736(20)32532-0.
• Aldana-Aguirre JC, Pinto M, Featherstone RM, Kumar M. Less invasive surfactant administration versus intubation for surfactant delivery in preterm infants with respiratory distress syndrome: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2017 Jan;102(1):F17-F23. doi: 10.1136/archdischild-2015-310299. Epub 2016 Nov 15.
• Geraghty LE, Dunne EA, Ni Chathasaigh CM, Vellinga A, Adams NC, O'Currain EM, McCarthy LK, O'Donnell CPF. Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants. N Engl J Med. 2024 May 30;390(20):1885-1894. doi: 10.1056/NEJMoa2402785. Epub 2024 May 5.
• Riva T, Engelhardt T, Basciani R, Bonfiglio R, Cools E, Fuchs A, Garcia-Marcinkiewicz AG, Greif R, Habre W, Huber M, Petre MA, von Ungern-Sternberg BS, Sommerfield D, Theiler L, Disma N; OPTIMISE Collaboration. Direct versus video laryngoscopy with standard blades for neonatal and infant tracheal intubation with supplemental oxygen: a multicentre, non-inferiority, randomised controlled trial. Lancet Child Adolesc Health. 2023 Feb;7(2):101-111. doi: 10.1016/S2352-4642(22)00313-3. Epub 2022 Nov 24.
• Kurepa D, Boyar V, Predtechenska O, Gupta V, Weinberger B, Pulju M, Zaytseva A, Galanti SG, Kasniya G, Perveen S. Video laryngoscopy-assisted less-invasive surfactant administration quality improvement initiative. Arch Dis Child Fetal Neonatal Ed. 2023 Nov;108(6):588-593. doi: 10.1136/archdischild-2023-325357. Epub 2023 Apr 7.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: video laryngoscopy; neonatal; less invasive surfactant
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: STU20250457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No