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Recruiting NCT07550218

NCT07550218 Surfactant Administration Methods in Preterm Infants With RDS: A Swedish Cohort Study

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Clinical Trial Summary
NCT ID NCT07550218
Status Recruiting
Phase —
Sponsor Vastra Gotaland Region
Condition Respiratory Distress Syndrome (& [Hyaline Membrane Disease])
Study Type OBSERVATIONAL
Enrollment 300 participants
Start Date 2026-05-25
Primary Completion 2029-05-25

Eligibility & Interventions

Sex All sexes
Min Age N/A
Max Age N/A
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 300 participants in total. It began in 2026-05-25 with a primary completion date of 2029-05-25.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 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

Contact & Investigator

Central Contact

Anders Elfvin, Professor

✉ anders.elfvin@vgregion.se

📞 +46313438073

Principal Investigator

Anders Elfvin, Professor

PRINCIPAL INVESTIGATOR

Department of Neonatology, Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Region Västra Götaland, Sweden

Frequently Asked Questions

Who can join the NCT07550218 clinical trial?

This trial is open to participants of all sexes, studying Respiratory Distress Syndrome (& [Hyaline Membrane Disease]). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07550218 currently recruiting?

Yes, NCT07550218 is actively recruiting participants. Contact the research team at anders.elfvin@vgregion.se for enrollment information.

Where is the NCT07550218 trial being conducted?

This trial is being conducted at Gothenburg, Sweden.

Who is sponsoring the NCT07550218 clinical trial?

NCT07550218 is sponsored by Vastra Gotaland Region. The principal investigator is Anders Elfvin, Professor at Department of Neonatology, Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Region Västra Götaland, Sweden. The trial plans to enroll 300 participants.

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