Recruiting NCT07426016
Video vs. Direct Laryngoscopy for Less Invasive Surfactant Administration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Video Laryngoscopy, Direct Laryngoscopy.
- Who it may be relevant to
- Registry conditions: Respiratory Distress Syndrome (Neonatal), Surfactant Deficiency Syndrome Neonatal. Basic parameters: 0 Hours — 3 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Controlled Trial of Video-Laryngoscopy Intervention or Direct Laryngoscopy for Delivery of Less Invasive Surfactant Administration for Premature Infants
Overview
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?
Interventions
- Procedure Video Laryngoscopy
Video Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter - Procedure Direct Laryngoscopy
Direct Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter
Primary outcome measures
- Rate of first attempt success [Time frame: During procedure]
Secondary outcome measures (12)
- Duration of desaturation below 80% SpO2 (sec), [Time frame: during procedure]
- Duration of bradycardia (HR <100 bpm) [Time frame: procedure duration]
- Number of desaturation/bradycardia episodes [Time frame: during procedure]
- Number of surfactant installation attempts [Time frame: during procedure]
- Time to completion of surfactant installation [Time frame: during procedure]
- Time to insertion of thin catheter [Time frame: during procedure]
- Amount of surfactant in stomach at the end of the procedure [Time frame: within 5 min after procedure]
- Mean maximum fractioned inspired O2 used [Time frame: during procedure]
- Lowest oxygen saturation during catheter insertion [Time frame: during procedure]
- Fractionated inspired oxygen (FiO2) at 60 mins post procedure [Time frame: 60 minutes post-procedure]
- Lowest heart rate during catheter insertion [Time frame: during procedure]
- Cross over to alternative method [Time frame: during procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Parkland Hospital — Dallas
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. PMID 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. PMID 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. Lanc PMID 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. PMID 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 PMID 33308472
Identifiers
NCT: NCT07426016 · STU20250457