NCT04445571

Surfactant Administration by Insure or Thin Catheter

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 2 Days
• Healthy volunteers: Not accepted

Summary

This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy. It will provide valuable knowledge to improve clinical methodology and enhance lung protective treatment strategies for preterm infants.

Detailed description

To compare two approaches for surfactant administration during CPAP in preterm infants, the INSURE and the LISA technique, using premedication intubation protocols, and investigate aspects of safety, stress and pain, timely administration of the drug, response in oxygenation and pulmonary outcome. Our study asks whether (P) among infants born \<32 weeks' gestation with RDS (I) does surfactant administration with LISA and analgesia premedication (C) versus surfactant administration according to the INSURE protocol (O) improve oxygenation and reduce the rate of respiratory failure and need for intubation and mechanical ventilation (T) within 48 hours of the procedure Primary outcomes: 1. Positive effect: Oxygenation measured as arterial to alveolar ratio (a/A ratio) at 24 hours post-procedure. 2. Negative effect: Need for mechanical ventilation (MV) within 48 hours post-procedure. Safety outcomes: 1. Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration 2. Number of tries before successful intubation/placement of catheter 3. Positive pressure ventilation during the procedure - yes/no/duration (minutes) 4. Stress and pain (changes in heart rate, blood pressure and BIIP-scale)

Conditions

• RDS of Prematurity
• Surfactant Deficiency Syndrome Neonatal
• Analgesia

Interventions

Type	Name	Description
PROCEDURE	Thin catheter technique or standard ET-tube for surfactant administration	Surfactant administration by intubation with regular ET-tube followed by immediate extubation to CPAP (INSURE) or by thin catheter during spontaneous breathing and continued CPAP.

Timeline

• Start date: 2021-05-21
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2020-06-24
• Last updated: 2025-07-01

Locations

1 site across 1 country: Sweden