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 type | Observational |
|---|---|
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Status | Recruiting |
| Started | May 25, 2026 |
| Main results expected | May 25, 2029 |
| Study ends | October 25, 2029 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT07550218 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
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study tests whether using a lung ultrasound score can speed up diagnosing severe RDS and getting surfactant to moderately and late-preterm babies in the NICU.
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This trial tests whether using video laryngoscopy helps give surfactant on the first try more often than direct laryngoscopy in extremely preterm babies needing surfactant.
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This will see if poractant alfa or calfactant given through a thin catheter (LISA) helps preterm infants under 30 weeks with respiratory distress who are breathing on noninvasive support.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.