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Actively Recruiting

Phase Not Applicable
Age: 0 - 2Days
All Genders
ID04445571

Comparing Surfactant Delivery Methods in Preterm Infants Under 32 Weeks Using Thin Catheter or INSURE Technique with Pain Medication

Led by Karolinska Institutet · Updated on 2025-07-01

160

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to compare two methods of surfactant administration in preterm infants born before 32 weeks of gestation with respiratory distress syndrome RDS. It evaluates the safety and effectiveness of the thin catheter technique combined with analgesic premedication against the established INSURE strategy. The study focuses on improving lung protective treatments and clinical practices for these vulnerable infants. The trial involves two groups one receiving surfactant via intubation with a regular endotracheal tube followed by immediate extubation to CPAP the INSURE protocol, and the other receiving surfactant through a thin catheter during spontaneous breathing with ongoing CPAP the LISA technique. Both groups receive analgesic premedication as part of the procedure. Participants will be monitored for oxygenation levels 24 hours after the procedure and the need for mechanical ventilation within 48 hours. Researchers will also assess safety outcomes such as timing of surfactant administration, number of intubation attempts, use and duration of positive pressure ventilation, and stress and pain indicators. Secondary outcomes include duration of ventilatory support, complications, mortality, and length of hospital stay until discharge.

CONDITIONS

Brief Title

Surfactant Administration by Insure or Thin Catheter

Research Team

K

Kajsa Bohlin, MD

M

Mats Blennow, MD

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