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

Neonatology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05024435
• Other study ID #: 415-E/2532/7-2019
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: August 2021
• Source: Salzburger Landeskliniken
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Neonatology
• Syndrome

Intervention

Device:
• Surfactant Administration
Laryngoscopy, intratracheal catheter placement and surfactant administration

Locations

Country	Name	City	State
Austria	Salzburger Landeskliniken	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Salzburger Landeskliniken

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful intratracheal tube Placement		Birth to 24 hours after birth