AzTrials
AzTrials

Respiratory Distress Syndrome (Neonatal)VID LISANCT07426016

Video vs. Direct Laryngoscopy for Less Invasive Surfactant Administration

A study testing Video Laryngoscopy and Direct Laryngoscopy in people with Respiratory Distress Syndrome (Neonatal) and Surfactant Deficiency Syndrome Neonatal, run by University of Texas Southwestern Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 0 hours to 3 days
What is being tested?
Video Laryngoscopy and Direct Laryngoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
11 Jun 2026to Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 hours to 3 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Principal Investigator, MD contact

214-648-3383

riti.chokshi@utsouthwestern.edu

United States1 site, 1 recruiting

  • Parkland Hospital

    Dallas, Texas, 75235

    Office of Research Administration, 214-645-8300, irb@utsouthwestern.edu

    Riti Chokshi, MD

    Recruiting

Other trials in United States

About this study

Official title: 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?

Being tested
Video Laryngoscopy, Direct Laryngoscopy
Keywords
less invasive surfactant, neonatal, video laryngoscopy
Medical subject headings
Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video LaryngoscopyProcedure or surgery

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

  • Direct LaryngoscopyProcedure or surgery

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

Study groups in NCT07426016
Study groupRoleWhat they receive
Video LaryngoscopyActive comparatorA video laryngoscopy will be used to visualize the vocal cords and place the LISA catheter for surfactant administration
Receives: Procedure: Video Laryngoscopy
Direct LaryngoscopyActive comparatorDirect laryngoscopy (no camera) will be used to visualize the vocal cords and place the LISA catheter for surfactant administration
Receives: Procedure: Direct Laryngoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of first attempt success

    Measured: During procedure

Secondary outcomes (19)

  1. Duration of desaturation below 80% SpO2 (sec),

    Measured: during procedure

  2. Duration of bradycardia (HR <100 bpm)

    Measured: procedure duration

  3. Number of desaturation/bradycardia episodes

    Measured: during procedure

  4. Number of surfactant installation attempts

    Measured: during procedure

  5. Time to completion of surfactant installation

    Measured: during procedure

  6. Time to insertion of thin catheter

    Measured: during procedure

  7. Amount of surfactant in stomach at the end of the procedure

    Measured: within 5 min after procedure

  8. Mean maximum fractioned inspired O2 used

    Measured: during procedure

  9. Lowest oxygen saturation during catheter insertion

    Measured: during procedure

  10. Fractionated inspired oxygen (FiO2) at 60 mins post procedure

    Measured: 60 minutes post-procedure

  11. Lowest heart rate during catheter insertion

    Measured: during procedure

  12. Cross over to alternative method

    Measured: during procedure

  13. Incidence of intubation at 72 hours post surfactant administration

    Measured: procedure to 72 hours post-procedure

  14. Incidence of pneumothorax

    Measured: procedure to 72 hours post-procedure

  15. Incidence of severe (grade III/IV) intraventricular hemorrhage

    Measured: Birth to discharge

  16. Continuous Positive Expiratory Pressure (CPAP) at 60 mins post procedure

    Measured: 60 minutes post-procedure

  17. Intubation during procedure

    Measured: During Procedure

  18. Change in provider during procedure

    Measured: during procedure

  19. Survival to discharge or 90 days

    Measured: up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2026
  2. Study start11 Jun 2026
  3. Primary completionJun 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07426016
Sponsor's protocol ID
STU20250457
Acronym
VID LISA
Status last verified
Jun 2026
First submitted
16 Feb 2026
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27852668

  • 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.

    PubMed 37028921

  • 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.

    PubMed 36436541

  • 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.

    PubMed 38709215

  • 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.

    PubMed 33308472

Questions about this trial

What is this clinical trial studying?

A study testing Video Laryngoscopy and Direct Laryngoscopy in people with Respiratory Distress Syndrome (Neonatal) and Surfactant Deficiency Syndrome Neonatal, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Principal Investigator, MD (214-648-3383, riti.chokshi@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of first attempt success (time frame: During procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07426016, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in