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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video Laryngoscopy | Active Comparator | A video laryngoscopy will be used to visualize the vocal cords and place the LISA catheter for surfactant administration |
|
| Direct Laryngoscopy | Active Comparator | Direct laryngoscopy (no camera) will be used to visualize the vocal cords and place the LISA catheter for surfactant administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Laryngoscopy | Procedure | Video Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of first attempt success | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of desaturation below 80% SpO2 (sec), | during procedure | |
| Duration of bradycardia (HR <100 bpm) | procedure duration | |
| Number of desaturation/bradycardia episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator, MD | Contact | 214-648-3383 | riti.chokshi@utsouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chokshi, MD | UT Southwestern | Principal Investigator |
| Shalini Ramachandran, MD | UT Southwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Hospital | Recruiting | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27852668 | Background | 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. | |
| 37028921 |
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| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Direct Laryngoscopy | Procedure | Direct Laryngoscopy will be used to visualize the vocal cords and place the LISA catheter |
|
| 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 |
| 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. |
| 36436541 | 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. |
| 38709215 | 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. |
| 33308472 | 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. |