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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorVastra Gotaland Region

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 4 trial groups
Group A: SALSA
Group B: LISA
Group C: INSURE
Group D: Group/Cohort Description: Intubation-Surfactant-Extubation. Followed by positive pressure ventilatio

Trial outcomes

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.

Time frame
Within 72 hours after first surfactant treatment

Secondary outcomes

1

Bradycardia <100 bpm (any duration)

Categorical variable (Yes/No). Measured by pulse oximetry and noted by team performing procedure.

Time frame
During the procedure, an average of 5-10 minutes
2

Oesophageal/upper airway injury

Categorical (Yes/No). Observations of infant during and post-procedure. Details provided if present.

Time frame
During and within an hour from procedure.
3

Bradycardia <60 bpm (any duration)

Categorical variable (Yes/No). Measured by pulse oximetry and noted by team performing procedure.

Time frame
During the procedure, an average of 5-10 minutes
4

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

Categorical variable (Yes/No). Measured by pulse oximetry and noted by team performing procedure.

Time frame
During the procedure, an average of 5-10 minutes

Other outcomes

1

Pain score

Continous variable. Using neonatal pain scale. Centre specific and scale may vary.

Time frame
Before, during and up to 1h after procedure

Sponsors and contacts

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Vastra Gotaland Region

Lead sponsor

Göteborg University

Collaborator