Infant Respiratory Distress Syndrome Clinical Trials

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A Prospective Observational Study of Surfactant AdministrationMethods for Preterm Infants With Respiratory Distress SyndromeWith Long-term Follow-up in the Swedish Neonatal Quality Register

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Sweden
Neonatal Intensive Care Unit, Sahlgrenska University Hostal
RECRUITING
Gothenburg
Contact Information
Primary
Anders Elfvin, Professor
anders.elfvin@vgregion.se
+46313438073
Backup
Mårten Larsson, M.D
marten.larsson@vgregion.se
+46704240972
Time Frame
Start Date: 2026-05-25
Estimated Completion Date: 2029-10-25
Participants
Target number of participants: 300
Treatments
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
Sponsors
Leads: Vastra Gotaland Region
Collaborators: Göteborg University

This content was sourced from clinicaltrials.gov