Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants
NCT ID: NCT07176117
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
422 participants
INTERVENTIONAL
2025-10-01
2031-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Prophylactic Surfactant
A single dose of surfactant (Curosurf) will be given via Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA). Infants who receive SALSA will remain on non-invasive respiratory support (Continuous Positive Airway Pressure).
Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA)
A single dose of surfactant will be given via Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA). A supraglottic airway device will be used as a standardized procedure for surfactant administration via SALSA using an AirLife Air-Q.
Expectant Management (CPAP)
For participating infants randomly assigned to receive continuation of non-invasive respiratory support, they will remain on continuous positive airway pressure (CPAP).
Continuous Positive Airway Pressure (CPAP)
Infants to receive continuation of non-invasive respiratory support will remain on continuous positive airway pressure (CPAP).
Interventions
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Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA)
A single dose of surfactant will be given via Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA). A supraglottic airway device will be used as a standardized procedure for surfactant administration via SALSA using an AirLife Air-Q.
Continuous Positive Airway Pressure (CPAP)
Infants to receive continuation of non-invasive respiratory support will remain on continuous positive airway pressure (CPAP).
Eligibility Criteria
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Inclusion Criteria
* ≤ 6 hours old
* Respiratory Distress: \[Silverman Andersen Score (SAS) ≥ 5, or Respiratory Severity Score (RSS) ≥ 1.25\]
* Clinical decision for non-invasive respiratory support
* Written parental consent
Exclusion Criteria
* Major congenital or chromosomal anomalies
* Prior intubation or receipt of surfactant
* Known or suspected hypoxic ischemic encephalopathy (HIE)
* Known or suspected neuromuscular disorder
* Unanticipated survival
33 Weeks
38 Weeks
ALL
No
Sponsors
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Chiesi USA, Inc.
INDUSTRY
Sharp HealthCare
OTHER
Responsible Party
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Anup Katheria, M.D.
Principal Investigator
Principal Investigators
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Anup Katheria, MD
Role: PRINCIPAL_INVESTIGATOR
Sharp HealthCare
Locations
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Sharp Chula Vista Medical Center
Chula Vista, California, United States
Sharp Grossmont Hospital
La Mesa, California, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Ho JJ, Subramaniam P, Davis PG. Continuous positive airway pressure (CPAP) for respiratory distress in preterm infants. Cochrane Database Syst Rev. 2020 Oct 15;10(10):CD002271. doi: 10.1002/14651858.CD002271.pub3.
Polin RA, Carlo WA; Committee on Fetus and Newborn; American Academy of Pediatrics. Surfactant replacement therapy for preterm and term neonates with respiratory distress. Pediatrics. 2014 Jan;133(1):156-63. doi: 10.1542/peds.2013-3443. Epub 2013 Dec 30.
Dargaville PA, Kamlin COF, Orsini F, Wang X, De Paoli AG, Kanmaz Kutman HG, Cetinkaya M, Kornhauser-Cerar L, Derrick M, Ozkan H, Hulzebos CV, Schmolzer GM, Aiyappan A, Lemyre B, Kuo S, Rajadurai VS, O'Shea J, Biniwale M, Ramanathan R, Kushnir A, Bader D, Thomas MR, Chakraborty M, Buksh MJ, Bhatia R, Sullivan CL, Shinwell ES, Dyson A, Barker DP, Kugelman A, Donovan TJ, Tauscher MK, Murthy V, Ali SKM, Yossuck P, Clark HW, Soll RF, Carlin JB, Davis PG; OPTIMIST-A Trial Investigators. Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome: The OPTIMIST-A Randomized Clinical Trial. JAMA. 2021 Dec 28;326(24):2478-2487. doi: 10.1001/jama.2021.21892.
Ramaswamy VV, Bandyopadhyay T, Abiramalatha T, Pullattayil S AK, Szczapa T, Wright CJ, Roehr CC. Clinical decision thresholds for surfactant administration in preterm infants: a systematic review and network meta-analysis. EClinicalMedicine. 2023 Jul 20;62:102097. doi: 10.1016/j.eclinm.2023.102097. eCollection 2023 Aug.
Ramaswamy VV, Abiramalatha T, Bandyopadhyay T, Boyle E, Roehr CC. Surfactant therapy in late preterm and term neonates with respiratory distress syndrome: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2022 Jul;107(4):393-397. doi: 10.1136/archdischild-2021-322890. Epub 2021 Oct 22.
Calevo MG, Veronese N, Cavallin F, Paola C, Micaglio M, Trevisanuto D. Supraglottic airway devices for surfactant treatment: systematic review and meta-analysis. J Perinatol. 2019 Feb;39(2):173-183. doi: 10.1038/s41372-018-0281-x. Epub 2018 Dec 5.
Lockyear C, Coe K, Greenberg RG, Clark RH, Aleem S. Trends in morbidities of late preterm infants in the neonatal intensive care unit. J Perinatol. 2023 Nov;43(11):1379-1384. doi: 10.1038/s41372-023-01705-5. Epub 2023 Jul 1.
Katheria A, Ines F, Banerji A, Hopper A, Uy C, Chundu A, Coughlin K, Hutson S, Morales A, Sauberan J, Poeltler D, Dorner R, Rich W, Finer N. Caffeine and Less Invasive Surfactant Administration for Respiratory Distress Syndrome of the Newborn. NEJM Evid. 2023 Dec;2(12):EVIDoa2300183. doi: 10.1056/EVIDoa2300183. Epub 2023 Nov 21.
Jackson W, Taylor G, Bamat NA, Zimmerman K, Clark R, Benjamin DK, Laughon MM, Greenberg RG, Hornik CP. Outcomes associated with surfactant in more mature and larger premature infants with respiratory distress syndrome. J Perinatol. 2020 Aug;40(8):1171-1177. doi: 10.1038/s41372-020-0625-1. Epub 2020 Feb 20.
Berger DS, Garg B, Penfield CA, Caughey AB. Respiratory distress syndrome is associated with increased morbidity and mortality in late preterm births. Am J Obstet Gynecol MFM. 2024 Jun;6(6):101374. doi: 10.1016/j.ajogmf.2024.101374. Epub 2024 Apr 5.
Olivier F, Nadeau S, Caouette G, Piedboeuf B. Association between Apnea of Prematurity and Respiratory Distress Syndrome in Late Preterm Infants: An Observational Study. Front Pediatr. 2016 Sep 26;4:105. doi: 10.3389/fped.2016.00105. eCollection 2016.
Consortium on Safe Labor; Hibbard JU, Wilkins I, Sun L, Gregory K, Haberman S, Hoffman M, Kominiarek MA, Reddy U, Bailit J, Branch DW, Burkman R, Gonzalez Quintero VH, Hatjis CG, Landy H, Ramirez M, VanVeldhuisen P, Troendle J, Zhang J. Respiratory morbidity in late preterm births. JAMA. 2010 Jul 28;304(4):419-25. doi: 10.1001/jama.2010.1015.
Spong CY, Mercer BM, D'Alton M, Kilpatrick S, Blackwell S, Saade G. Timing of indicated late-preterm and early-term birth. Obstet Gynecol. 2011 Aug;118(2 Pt 1):323-333. doi: 10.1097/AOG.0b013e3182255999.
Other Identifiers
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SPLASH
Identifier Type: -
Identifier Source: org_study_id
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