Surfactant Administration Methods in Preterm Infants With RDS: A Swedish Cohort Study

NCT07550218 | Not Yet Recruiting

• 1 other identifier: DNR 2026-00189-01
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to evaluate different methods of surfactant administration in preterm infants with respiratory distress syndrome (RDS). Preterm infants often have immature lungs and a deficiency of surfactant, a substance that helps keep the lungs open and supports oxygen exchange.Surfactant can be delivered to the lungs using different techniques, including INSURE (brief intubation), LISA (via a thin catheter), SALSA (via a laryngeal mask airway), and traditional administration via endotracheal intubation followed by mechanical ventilation. The main question this study aims to answer is:Which method of surfactant administration is associated with better clinical outcomes in preterm infants with RDS?The study will prospectively collect clinical data on infants receiving surfactant as part of standard care, with long-term follow-up using data from the Swedish Neonatal Quality Register. The results are intended to be used to inform the design of a future randomized multicenter study.

Conditions

Respiratory Distress Syndrome (Neonatal); Respiratory Distress Syndrome (RDS); Respiratory Distress Syndrome (& [Hyaline Membrane Disease]); Respiratory Distress Syndrome of Newborn; Respiratory Distress Syndrome in Premature Infant

Keywords

Preterm infants; Premature infants; Surfactant therapy; Supraglottic Airway; Laryngeal Mask Airway; Intubation; LISA; INSURE; Less Invasive Surfactant Therapy; SALSA; Surfactant via Laryngeal or Supraglottic Airway; RDS; Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• Mechanical ventilation or repeat surfactant within 72 hours after first surfactant treatment delivered by LISA, SALSA or INSURE method

  Categorical variable (Yes/No). Decision to initiate mechanical ventilation via intubation will be made at the discretion of the treating physician, guided by the local NICU criteria for mechanical ventilation. Data is extracted from medical records.

  Within 72 hours after first surfactant treatment

Secondary Outcomes (92)

• Bradycardia <100 bpm (any duration)

  During the procedure, an average of 5-10 minutes

• Oesophageal/upper airway injury

  During and within an hour from procedure.

• Bradycardia <60 bpm (any duration)

  During the procedure, an average of 5-10 minutes

• Desaturation to SpO₂ <80% lasting ≥30 seconds (single episode)

  During the procedure, an average of 5-10 minutes

• Duration of bradycardia <100 and <60 bpm

  During the procedure, an average of 5-10 minutes

Other Outcomes (1)

• Pain score

  Before, during and up to 1h after procedure

Study Arms (4)

SALSA

Surfactant Administration via Laryngeal or Supraglottic Airway

LISA

Less Invasive Surfactant Administration using a thin catheter applied below the vocal cords guided by laryngoscopy

INSURE

Intubation-Surfactant-Extubation. Followed by positive pressure ventilation or brief period (\<1 hour) of mechanical ventilation

Group/Cohort Description: Intubation-Surfactant-Extubation. Followed by positive pressure ventilatio

Continued on mechanical ventilation \>1 hour

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newborn infants admitted to neonatal units in Västra Götaland Region, Sweden.

You may qualify if:

• Patient has received surfactant by any administration method
• Gestational age below 37 weeks'
• First surfactant treatment given before 48 hours of age
• Confirmed or suspected diagnosis of respiratory distress syndrome (RDS)

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Related Publications (3)

• Abdel-Latif ME, Davis PG, Wheeler KI, De Paoli AG, Dargaville PA. Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2021 May 10;5(5):CD011672. doi: 10.1002/14651858.CD011672.pub2.

  PMID: 33970483 BACKGROUND

• Abdel-Latif ME, Walker E, Osborn DA. Laryngeal mask airway surfactant administration for prevention of morbidity and mortality in preterm infants with or at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2024 Jan 25;1(1):CD008309. doi: 10.1002/14651858.CD008309.pub3.

  PMID: 38270182 BACKGROUND

• Sweet DG, Carnielli VP, Greisen G, Hallman M, Klebermass-Schrehof K, Lavizzari A, Ozek E, Te Pas A, Roehr CC, Saugstad OD, Simeoni U, Vento M, Visser GHA, Speer CP. European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2025. Neonatology. 2026 Mar 9:1-26. doi: 10.1159/000551062. Online ahead of print.

  PMID: 41802129 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hyaline Membrane Disease; Pulmonary Atelectasis; Premature Birth

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Distress Syndrome, Newborn; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Anders Elfvin, Professor

  Department of Neonatology, Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Region Västra Götaland, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Elfvin, Professor

CONTACT

+46313438073; anders.elfvin@vgregion.se

Mårten Larsson, M.D

CONTACT

+46704240972; marten.larsson@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 24, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): April 27, 2029
• Study Completion (Estimated): August 27, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04