Video vs. Direct Laryngoscopy for Less Invasive Surfactant Administration

NCT07426016 | Not Yet Recruiting

• 1 other identifier: STU20250457
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

less invasive surfactant; neonatal; video laryngoscopy

Outcome Measures

Primary Outcomes (1)

• Rate of first attempt success

  During procedure

Secondary Outcomes (19)

• 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

Study Arms (2)

Video Laryngoscopy

ACTIVE COMPARATOR

A video laryngoscopy will be used to visualize the vocal cords and place the LISA catheter for surfactant administration

Procedure: Video Laryngoscopy

Direct Laryngoscopy

ACTIVE COMPARATOR

Direct laryngoscopy (no camera) will be used to visualize the vocal cords and place the LISA catheter for surfactant administration

Procedure: Direct Laryngoscopy

Interventions

Video Laryngoscopy PROCEDURE

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

Video Laryngoscopy

Direct Laryngoscopy PROCEDURE

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

Direct Laryngoscopy

Eligibility Criteria

• Age: 0 Hours - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75235, United States

Location

Related Publications (5)

• 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.

  PMID: 27852668 BACKGROUND

• 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.

  PMID: 37028921 BACKGROUND

• 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.

  PMID: 36436541 BACKGROUND

• 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.

  PMID: 38709215 BACKGROUND

• 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.

  PMID: 33308472 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chokshi, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

• Shalini Ramachandran, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)