Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants

Официальное название

A Clinical Trial Comparing Surfactant Administration Through Supraglottic Airway or Thin Catheter for Preterm Infants

Обзор

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?

Вмешательства

• Процедура Surfactant Administration through Laryngeal or Supraglottic Airway
  Surfactant Administration through Supraglottic Airway Devices * Air-Q3 size 0 for neonates: \< 2 kilograms * i-gel supraglottic airway size 1 for neonates: ≥ 2 kilograms
• Процедура Surfactant Administration through Thin Catheter
  Thin Catheter

Первичные конечные точки

• Number of events of bradycardia and hypoxemia during surfactant administration [Срок оценки: Time of surfactant administration to completion of procedure]

Вторичные конечные точки (4)

• Procedural success rate on first attempt [Срок оценки: At time of surfactant administration procedure]
• Intubation rate [Срок оценки: From time of procedure to 72 hours of life]
• Mean number of attempts required [Срок оценки: At time of surfactant administration]
• Total duration of CPAP and mechanical ventilation days [Срок оценки: Up to 52 weeks]

Критерии участия

Критерии включения

• All preterm infants born at or greater than 29 weeks' gestational age
• Infants with birthweight greater than or equal to 750 grams and admitted to the NICU on CPAP for respiratory support and qualify for LISA procedure

Критерии исключения

• Infants who require intubation prior to surfactant therapy
• Infants with known severe congenital anomalies (complex congenital heart disease, airway and central nervous system anomalies)
• Infants whose birth weight is less than 750 grams or oropharynx unable to accommodate laryngeal mask airways

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 32989046
• 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. PMID 29174079
• 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 D PMID 36336195
• 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. PMID 35986148
• 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. PMID 30635595
• 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. PMID 34552000
• 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. PMID 24379228

Идентификаторы

NCT: NCT07030270 · STU20250018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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