Surfactant Administration by Insure or Thin Catheter
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Analgesia
- RDS of Prematurity
- Surfactant Deficiency Syndrome Neonatal
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomised controlled trialMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 2 years
- Gender
- Both males and females
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. O...
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: Positive effect: Oxygenation measured as arterial to alveolar ratio (a/A ratio) at 24 hours post-procedure. Negative effect: Need for mechanical ventilation (MV) within 48 hours post-procedure. Safety outcomes: Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration Number of tries before successful intubation/placement of catheter Positive pressure ventilation during the procedure - yes/no/duration (minutes) Stress and pain (changes in heart rate, blood pressure and BIIP-scale)
Tracking Information
- NCT #
- NCT04445571
- Collaborators
- Not Provided
- Investigators
- Not Provided