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

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

Study Overview

• Status: Completed
• Conditions: Neonatology; Perinatal Distress Syndrome
• Intervention / Treatment: Device: Surfactant Administration

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Salzburger Landeskliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasogastric Tube	Device: Surfactant Administration; Laryngoscopy, intratracheal catheter placement and surfactant administration
Experimental: Lisacath	Device: Surfactant Administration; Laryngoscopy, intratracheal catheter placement and surfactant administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Successful intratracheal tube Placement	Birth to 24 hours after birth

Collaborators and Investigators

• Sponsor: Salzburger Landeskliniken
• Investigators: Principal Investigator: Martin Wald, MD, Assoc. Prof., Paracelsus Medical Private University Salzburg, University Clinic of Pediatrics and Adolescent Medicine Division of Neonatology

Publications and helpful links

General Publications

• Auer-Hackenberg L, Brandner J, Hofstatter E, Stroicz P, Hager T, Eichhorn A, Schutz S, Feldner R, Wald M. A pilot study of evaluation of semi-rigid and flexible catheters for less invasive surfactant administration in preterm infants with respiratory distress syndrome-a randomized controlled trial. BMC Pediatr. 2022 Nov 4;22(1):637. doi: 10.1186/s12887-022-03714-3.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Surfactant; Respiratory Distress Syndrome; Preterm Infant; Less Invasive Surfactant Administration; Minimal Invasive Surfactant Treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Syndrome; Respiratory Distress Syndrome; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: 415-E/2532/7-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No