About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial population
Newborn infants admitted to neonatal units in Västra Götaland Region, Sweden.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Bradycardia <100 bpm (any duration)
Categorical variable (Yes/No). Measured by pulse oximetry and noted by team performing procedure.
Oesophageal/upper airway injury
Categorical (Yes/No). Observations of infant during and post-procedure. Details provided if present.
Bradycardia <60 bpm (any duration)
Categorical variable (Yes/No). Measured by pulse oximetry and noted by team performing procedure.
Desaturation to SpO₂ <80% lasting ≥30 seconds (single episode)
Categorical variable (Yes/No). Measured by pulse oximetry and noted by team performing procedure.
Other outcomes
Pain score
Continous variable. Using neonatal pain scale. Centre specific and scale may vary.
Sponsors and contacts
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Vastra Gotaland Region
Lead sponsor
Göteborg University
Collaborator