Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants

NCT07176117 | Not Yet Recruiting DMC

• 1 other identifier: SPLASH
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this research is to learn new information that may help other infants that have respiratory distress syndrome and need breathing support after birth. The goal of this research is to see if continuous positive airway pressure (CPAP) alone or CPAP with surfactant administration through a less invasive method via an Airway Device (supraglottic airway device) temporarily placed above the vocal cords is better for treating respiratory distress syndrome in late preterm and early term infants.

Conditions

Respiratory Distress Syndrome (Neonatal); Surfactant

Keywords

supraglottic airway device

Outcome Measures

Primary Outcomes (1)

• Difference in Ranked Composite of Morbidities

  Determine if there is a difference in ranked composite of morbidities including death, development of pneumothorax/ pulmonary air leaks, Respiratory Severity Score (RSS), time to initial feeding, and LOS (length of hospital stay) between the treatment and control groups using a linked count of participants who fall within each prespecified rank.

  From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.

Secondary Outcomes (1)

• Length of Hospital Stay

  From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.

Other Outcomes (13)

• Time to Parent Bonding

  From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.

• Duration of Mechanical Ventilation

  From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.

• Duration of Continuous Positive Airway Pressure

  From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.

Study Arms (2)

Prophylactic Surfactant

EXPERIMENTAL

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).

Procedure: Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA)

Expectant Management (CPAP)

ACTIVE COMPARATOR

For participating infants randomly assigned to receive continuation of non-invasive respiratory support, they will remain on continuous positive airway pressure (CPAP).

Procedure: Continuous Positive Airway Pressure (CPAP)

Interventions

Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA) PROCEDURE

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.

Prophylactic Surfactant

Continuous Positive Airway Pressure (CPAP) PROCEDURE

Infants to receive continuation of non-invasive respiratory support will remain on continuous positive airway pressure (CPAP).

Expectant Management (CPAP)

Eligibility Criteria

• Age: 33 Weeks - 38 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborns 33-38+6 weeks gestation at birth
• ≤ 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

You may not qualify if:

• Surrogate deliveries
• 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

Sponsors & Collaborators

• Sharp HealthCare: lead
• Chiesi USA, Inc.: collaborator

Study Sites (3)

Sharp Chula Vista Medical Center

Chula Vista, California, 91911, United States

Location

Sharp Grossmont Hospital

La Mesa, California, 91942, United States

Location

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, 92123, United States

Location

Related Publications (13)

• 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.

  PMID: 33058208 BACKGROUND

• 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.

  PMID: 24379227 BACKGROUND

• 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.

  PMID: 34902013 BACKGROUND

• 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.

  PMID: 37538537 BACKGROUND

• 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.

  PMID: 34686533 BACKGROUND

• 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.

  PMID: 30518796 BACKGROUND

• 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.

  PMID: 37393396 BACKGROUND

• 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.

  PMID: 38320499 BACKGROUND

• 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.

  PMID: 32080333 BACKGROUND

• 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.

  PMID: 38583712 BACKGROUND

• 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.

  PMID: 27725928 BACKGROUND

• 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.

  PMID: 20664042 BACKGROUND

• 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.

  PMID: 21775849 BACKGROUND

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Anup Katheria, MD

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anup Katheria, MD

CONTACT

858-939-4170; anup.katheria@sharp.com

Catherine Peterson, MS

CONTACT

catherine.peterson1@sharp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 16, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months and ending 36 months following article publication.
• Access Criteria: Data and publication are available at http://clinicaltrials.gov

Locations

US (3)