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NCT06758492: NEU-VODEtec

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

Recruiting now Last updated 20 February 2025
What this trial tests

trial testing Video laryngoscopy used to insert thin endotracheal catheter in Respiratory Distress Syndrome (Neonatal) in 600 participants. Currently enrolling.

Timeline
13 January 2025
Primary endpoint
13 December 2025
31 December 2025

Quick facts

Lead sponsorUniversity College Dublin
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment600
Start date13 January 2025
Primary completion13 December 2025
Estimated completion31 December 2025
Sites16 locations across Italy, Greece, Hungary, Norway, Poland, Romania, Croatia, Spain

Drugs / interventions tested

Conditions studied

Sponsor

University College Dublin

Who can join

Adults 0 Minutes to 28 Days, any sex, with Respiratory Distress Syndrome (Neonatal) or Respiratory Distress Syndrome (RDS). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Respiratory Distress Syndrome (Neonatal)

Currently open trials in the same condition.

Other University College Dublin trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06758492.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing