NCT05024435

Evaluation of Semi-rigid and Flexible Catheters for Less Invasive Surfactant Administration in Preterm Infants

Evaluation of Semi-rigid and Flexible Catheters for Less Invasive Surfactant Administration in Preterm Infants With Respiratory Distress Syndrome - A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Salzburger Landeskliniken · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The overall aim of this study is to determine the differences between two surfactant administration catheters in preterm infants.

Detailed description

In this single-center, open-label, randomized-controlled trial, preterm infants requiring surfactant administration after birth, using a standardized minimal invasive protocol, were randomised to two different modes of endotracheal catheterization: Flexible Ch-4 feeding tube inserted using Magill forceps (group 1) and semi-rigid catheter (group 2). Primary outcome was duration of laryngoscopy. Secondary outcomes were complication rate and vital parameters during laryngoscopy.

Conditions

• Neonatology
• Perinatal Distress Syndrome

Interventions

Type	Name	Description
DEVICE	Surfactant Administration	Laryngoscopy, intratracheal catheter placement and surfactant administration

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2021-08-27
• Last updated: 2021-09-02

Locations

1 site across 1 country: Austria