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

NCT07030270 | Recruiting DMC

• 1 other identifier: STU20250018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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 above the vocal cords ("Surfactant Administration through Laryngeal or Supraglottic Airway", called the SALSA method). The goal is to see which method is safer and more effective for preterm infants who are born at 29-36 weeks of pregnancy and have trouble breathing. What is the main question (hypothesis)? Infants who receive surfactant using the SALSA method will have fewer heart rate and breathing-related problems 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?

Conditions

Respiratory Distress Syndrome (Neonatal); Surfactant

Keywords

preterm infants; surfactant therapy; respiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

• Combined bradycardia (heart rate < 100 for > 10 seconds) and hypoxemia (SpO2 < 80% for > 30 seconds) during surfactant administration

  * Bradycardia: defined as heart rate \< 100 beats per minute for \> 10 seconds. Heart rate will be obtained from participant's heart rate monitor. * Hypoxemia: oxygen saturation (SpO2) =\< 80% for \> 30 seconds. Oxygen saturation will be obtained from participant's pulse oximeter monitor * Events will be recorded by bedside respiratory therapy and/or bedside nurse during the procedure

  Time of laryngoscope or supraglottic airway device insertion to removal of device

Secondary Outcomes (4)

• Procedural success rate on first attempt

  At time of surfactant administration procedure

• Intubation rate

  From time of procedure to 72 hours of life

• Mean number of attempts required

  At time of surfactant administration

• Total duration of CPAP and mechanical ventilation days

  Up to 52 weeks

Study Arms (2)

Surfactant Administration through Laryngeal or Supraglottic Airway

EXPERIMENTAL

Procedure: Surfactant Administration through Laryngeal or Supraglottic Airway

Surfactant Administration through Thin Catheter

ACTIVE COMPARATOR

Procedure: Surfactant Administration through Thin Catheter

Interventions

Surfactant Administration through Thin Catheter PROCEDURE

Thin Catheter

Surfactant Administration through Thin Catheter

Surfactant Administration through Laryngeal or Supraglottic Airway PROCEDURE

Surfactant Administration through Supraglottic Airway Devices -AerVia sizes S, M, L, XL

Surfactant Administration through Laryngeal or Supraglottic Airway

Eligibility Criteria

• Age: 0 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All preterm infants born between 29-36 weeks' gestation.
• Infants with birthweight greater than or equal to 750 grams and admitted to the NICU on CPAP for respiratory support requiring at least FiO2 25% and qualify for LISA procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Health and Hospital Systems

Dallas, Texas, 75235, United States

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 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.

  PMID: 36336195 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.

  PMID: 35986148 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.

  PMID: 30635595 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.

  PMID: 34552000 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.

  PMID: 24379228 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Melody Chiu, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melody Chiu, M.D.

CONTACT

214-648-3903; melody.chiu@utsouthwestern.edu

Kathryn Mazioniene, R.N.

CONTACT

kathryn.mazioniene@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 22, 2025
• Study Start: August 5, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: September 16, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)