Clinical Trial

A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants

Study acronym: NEU-VODEtec
Recruiting
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Record status
This record was last updated February 20, 2025 (before its estimated December 13, 2025 completion). Its status may not reflect the trial's current state.
Summary
Many premature babies have breathing difficulty after birth and receive help with a breathing machine (nasal continuous positive airway pressure, NCPAP). Some of the babies whose breathing gets worse despite NCPAP are treated with surfactant, a medication that is given directly into their windpipe (trachea). Some of the babies who are given surfactant get it through a ventilation tube (endotracheal tube, ETT), while others get it through a thin catheter that is too small for ventilation. When doctors insert a tube or a thin catheter into the windpipe of a baby, they use an instrument called a laryngoscope, which has a light at its tip, to identify the entrance. Most often doctors look directly into the baby's mouth with a standard laryngoscope to identify the entrance to the windpipe. However, newer video laryngoscopes have a camera along with the light at their tip, which displays a picture of the entrance to the windpipe on a screen. In a study performed at one hospital, doctors inserted an ETT first time more often when they used a video laryngoscope. The investigators are doing a study at many hospitals where doctors usually use a standard laryngoscope to insert tubes and thin catheters into a baby's trachea by looking directly into the mouth. Each hospital will switch one-by-one to using a video laryngoscope when inserting a tube. The investigators will compare the information we collect to see if more babies who have a tube inserted first time without falls in their oxygen levels or heart rate with a video laryngoscope. The investigators will also collect information on babies who have a thin catheter inserted to compare whether doctors use fewer attempts when they use a video laryngoscope.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-01-02; most recent amendment 2025-02-18.
Status change: Not Yet Recruiting → Recruiting 2025-02-04
Trial Details
NCT Number NCT06758492
Lead Sponsor University College Dublin
Collaborators: Leiden University Medical Center
Conditions Respiratory Distress Syndrome (Neonatal), Respiratory Distress Syndrome (RDS), Video Laryngoscopy, Surfactant
Enrollment 600 participants
Start Date 2025-01-13
Primary Completion 2025-12-13 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-20