Surfactant Administration by Insure or Thin Catheter — SAINT  

Analgesia Clinical Trial

Official title: Surfactant Administration by Insure or Thin Catheter

Status Recruiting

Clinical Trial 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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Analgesia
• RDS of Prematurity
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Surfactant Deficiency Syndrome Neonatal

• NCT number: NCT04445571
• Study type: Interventional
• Source: Karolinska Institutet
• Contact: Kajsa Bohlin, MD
• Phone: +46858580000
• Email: kajsa.bohlin@ki.se
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2021
• Completion date: December 31, 2025