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Completed

NCT Number: NCT05024435

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Surfactant Administration

Device

Laryngoscopy, intratracheal catheter placement and surfactant administration

Primary outcomes

  1. Successful intratracheal tube Placement

    Time frame: Birth to 24 hours after birth

Sponsors and collaborators

Lead sponsor

Salzburger Landeskliniken

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2021
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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