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What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better. Surfactant can be given using a thin tube ("Less Invasive Surfactant Administration", called the LISA method) or through a small airway device placed in the baby's throat ("Surfactant Administration through Laryngeal or Supraglottic Airway", called the SALSA method). The goal is to see which method is safer and more effective for infants who are born at or after 29 weeks of pregnancy and have trouble breathing.
What is the main question (hypothesis)? Infants who receive surfactant using the SALSA method will have fewer breathing-related problems and fewer short-term complications than those who receive it using the LISA method.
What are the aims? Aim 1: Are babies in the SALSA group less likely to have low heart rate or low oxygen levels during the procedure compared to babies in the LISA group? Aim 2: Do fewer babies in the SALSA group need to be put on a breathing machine within the first 72 hours of life? Aim 3: Does the SALSA method help reduce the overall time babies need breathing support and lower the cost of their care in the NICU?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surfactant Administration through Laryngeal or Supraglottic Airway | Experimental |
| |
| Surfactant Administration through Thin Catheter | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surfactant Administration through Laryngeal or Supraglottic Airway | Procedure | Surfactant Administration through Supraglottic Airway Devices
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of events of bradycardia and hypoxemia during surfactant administration |
| Time of surfactant administration to completion of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural success rate on first attempt |
| At time of surfactant administration procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melody Chiu, M.D. | Contact | 214-648-3903 | melody.chiu@utsouthwestern.edu | |
| Venkat Kakkilaya, M.D. | Contact | venkat.kakkilaya@utsouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melody Chiu, M.D. | University of Texas Southwestern Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32989046 | Background | Roberts CT, Manley BJ, O'Shea JE, Stark M, Andersen C, Davis PG, Buckmaster A. Supraglottic airway devices for administration of surfactant to newborn infants with respiratory distress syndrome: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2021 May;106(3):336-341. doi: 10.1136/archdischild-2020-319804. Epub 2020 Sep 28. | |
| 29174079 |
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Data will be collected and de-identified at the time of analysis. IPD availability does not to enhance study results.
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| Surfactant Administration through Thin Catheter | Procedure | Thin Catheter |
|
| Intubation rate |
| From time of procedure to 72 hours of life |
| Mean number of attempts required | Procedure attempt will be defined as introduction of laryngoscope blade into mouth. | At time of surfactant administration |
| Total duration of CPAP and mechanical ventilation days | Total numbers of days on continuous end positive expiratory pressure (CPAP) and invasive mechanical ventilation | Up to 52 weeks |
| Roberts KD, Brown R, Lampland AL, Leone TA, Rudser KD, Finer NN, Rich WD, Merritt TA, Czynski AJ, Kessel JM, Tipnis SM, Stepka EC, Mammel MC. Laryngeal Mask Airway for Surfactant Administration in Neonates: A Randomized, Controlled Trial. J Pediatr. 2018 Feb;193:40-46.e1. doi: 10.1016/j.jpeds.2017.09.068. Epub 2017 Nov 22. |
| 36336195 | Background | Wyckoff MH, Greif R, Morley PT, Ng KC, Olasveengen TM, Singletary EM, Soar J, Cheng A, Drennan IR, Liley HG, Scholefield BR, Smyth MA, Welsford M, Zideman DA, Acworth J, Aickin R, Andersen LW, Atkins D, Berry DC, Bhanji F, Bierens J, Borra V, Bottiger BW, Bradley RN, Bray JE, Breckwoldt J, Callaway CW, Carlson JN, Cassan P, Castren M, Chang WT, Charlton NP, Phil Chung S, Considine J, Costa-Nobre DT, Couper K, Couto TB, Dainty KN, Davis PG, de Almeida MF, de Caen AR, Deakin CD, Djarv T, Donnino MW, Douma MJ, Duff JP, Dunne CL, Eastwood K, El-Naggar W, Fabres JG, Fawke J, Finn J, Foglia EE, Folke F, Gilfoyle E, Goolsby CA, Granfeldt A, Guerguerian AM, Guinsburg R, Hirsch KG, Holmberg MJ, Hosono S, Hsieh MJ, Hsu CH, Ikeyama T, Isayama T, Johnson NJ, Kapadia VS, Kawakami MD, Kim HS, Kleinman M, Kloeck DA, Kudenchuk PJ, Lagina AT, Lauridsen KG, Lavonas EJ, Lee HC, Lin YJ, Lockey AS, Maconochie IK, Madar RJ, Malta Hansen C, Masterson S, Matsuyama T, McKinlay CJD, Meyran D, Morgan P, Morrison LJ, Nadkarni V, Nakwa FL, Nation KJ, Nehme Z, Nemeth M, Neumar RW, Nicholson T, Nikolaou N, Nishiyama C, Norii T, Nuthall GA, O'Neill BJ, Gene Ong YK, Orkin AM, Paiva EF, Parr MJ, Patocka C, Pellegrino JL, Perkins GD, Perlman JM, Rabi Y, Reis AG, Reynolds JC, Ristagno G, Rodriguez-Nunez A, Roehr CC, Rudiger M, Sakamoto T, Sandroni C, Sawyer TL, Schexnayder SM, Schmolzer GM, Schnaubelt S, Semeraro F, Skrifvars MB, Smith CM, Sugiura T, Tijssen JA, Trevisanuto D, Van de Voorde P, Wang TL, Weiner GM, Wyllie JP, Yang CW, Yeung J, Nolan JP, Berg KM; Collaborators. 2022 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations: Summary From the Basic Life Support; Advanced Life Support; Pediatric Life Support; Neonatal Life Support; Education, Implementation, and Teams; and First Aid Task Forces. Resuscitation. 2022 Dec;181:208-288. doi: 10.1016/j.resuscitation.2022.10.005. Epub 2022 Nov 3. |
| 35986148 | Background | Kakkilaya V, Gautham KS. Should less invasive surfactant administration (LISA) become routine practice in US neonatal units? Pediatr Res. 2023 Apr;93(5):1188-1198. doi: 10.1038/s41390-022-02265-8. Epub 2022 Aug 19. |
| 30635595 | Background | Kurepa D, Perveen S, Lipener Y, Kakkilaya V. The use of less invasive surfactant administration (LISA) in the United States with review of the literature. J Perinatol. 2019 Mar;39(3):426-432. doi: 10.1038/s41372-018-0302-9. Epub 2019 Jan 11. |
| 34552000 | Background | Kakkilaya VB, Weydig HM, Smithhart WE, Renfro SD, Garcia KM, Brown CM, He H, Wagner SA, Metoyer GC, Brown LS, Kapadia VS, Savani RC, Jaleel MA. Decreasing Continuous Positive Airway Pressure Failure in Preterm Infants. Pediatrics. 2021 Oct;148(4):e2020014191. doi: 10.1542/peds.2020-014191. Epub 2021 Sep 22. |
| 24379228 | Background | Committee on Fetus and Newborn; American Academy of Pediatrics. Respiratory support in preterm infants at birth. Pediatrics. 2014 Jan;133(1):171-4. doi: 10.1542/peds.2013-3442. Epub 2013 Dec 30. |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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