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

Not Applicable

Completed

• Conditions: Neonatology; Perinatal Distress Syndrome
• Interventions: Device: Surfactant Administration

• Registration Number: NCT05024435
• Lead Sponsor: Salzburger Landeskliniken

Brief 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.

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2021-08
• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-27
• Last Update Submitted: 2021-08-27
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Preterm infants born less than 37 weeks of gestation
• Treating physician in charge of admission decides to administer intratracheal surfactant via standardized institution- LISA protocol (regardless of this study) (see Supplement file 1)
• Written informed consent signed by caregivers or legal representative to participate

Exclusion Criteria

• Refusal to participate in study or not providing written informed consent by caregivers/parents
• Treating physician decides to use different route of surfactant administration or does not adhere to LISA protocol.
• Rupture of membranes (ROM) at less than 22 weeks of gestation or more than 6 weeks before birth
• Estimated birth weight < 3rd percentile using 2013 Fenton growth trajectories
• Twins with feto-fetal transfusion syndrome (FFTS) and FFTS being the cause of premature delivery
• Contraindications listed in the LISAcath® or Nasogastric Tube manual (esophageal/pharyngeal varices or other vascular lesions, esophageal/pharyngeal tumor, nasal fracture, skull fracture, known allergy to material)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasogastric Tube	Surfactant Administration	-
Lisacath	Surfactant Administration	-

Primary Outcome Measures

Name	Time	Method
Successful intratracheal tube Placement	Birth to 24 hours after birth

Trial Locations

Locations (1)

Salzburger Landeskliniken; 🇦🇹 Salzburg, Austria