Clinical trial Recruiting at 1 site Observational

Surfactant delivery methods in preterm infants with RDS in Sweden

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

Run by Vastra Gotaland Region · NCT07550218 · Data updated 2026-11-12

This study tests different ways of giving surfactant to preterm babies with respiratory distress to see which method works best when care is routine.

Quick facts

Study typeObservational
SexAll
Enrollment300 (estimated)
SponsorVastra Gotaland Region
Government
Locations1 site (Gothenburg)
StatusRecruiting
StartedMay 25, 2026
Main results expectedMay 25, 2029
Study endsOctober 25, 2029
Registry record updatedAugust 20, 2026
Trial IDNCT07550218 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Preterm infants (<37 weeks gestation) who received surfactant for suspected or confirmed RDS within 48 hours of birth.

Probably not a fit

Results may be less applicable to infants with atypical presentations or those receiving non-standard surfactant therapies.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects data on surfactant administration methods for preterm infants with RDS across Swedish neonatal units, using standard care as the setting. It compares approaches such as INSURE, LISA, SALSA, and traditional endotracheal administration, to observe associations with clinical outcomes. Data are gathered prospectively and linked to the Swedish Neonatal Quality Register for long-term follow-up, with the aim of informing future randomized trials. The analysis will explore real-world practice patterns, safety signals, and outcome trends across participating centers. The study emphasizes non-randomized, observational assessment rather than experimental intervention.

Why it matters

Potential benefit: If successful, findings could guide clinicians toward surfactant delivery methods associated with better outcomes in preterm infants with RDS.

How similar studies have gone: Prior European guidance supports less invasive approaches like LISA, but direct comparative effectiveness data in real-world settings remain limited, making this observational effort important and somewhat exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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)

Exclusion Criteria:

• Not fulfilling above inclusion criteria

Where it's running

  • Neonatal Intensive Care Unit, Sahlgrenska University Hostal
    Gothenburg, Sweden
    Recruiting

Study contacts

  • Principal investigator: Anders Elfvin, Professor — Department of Neonatology, Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Region Västra Götaland, Sweden
  • Study coordinator: Anders Elfvin, Professor
  • Email: anders.elfvin@vgregion.se
  • Phone: +46313438073

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.