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RECRUITING
NCT06758492

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

Sponsor: University College Dublin

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

0 Minutes - 28 Days

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2025-01-13

Completion Date

2025-12-31

Last Updated

2025-02-20

Healthy Volunteers

No

Interventions

DEVICE

Video laryngoscopy used to insert thin endotracheal catheter

Video laryngoscopy used to insert thin endotracheal catheter

DEVICE

Direct laryngoscopy used to insert thin endotracheal catheter

Direct laryngoscopy used to insert thin endotracheal catheter

Locations (16)

Clinical Hospital Centre

Rijeka, Croatia

Clinical Hospital "Holy Spirit"

Zagreb, Croatia

University Hospital Brno

Brno, Czechia

General University Hospital

Prague, Czechia

Institute for Mother and Child Care

Prague, Czechia

Aristotle University of Thessaloniki

Thessaloniki, Greece

Second Semmelweiss University

Budapest, Hungary

University of Padova

Padova, Italy

Oslo University Hospital

Oslo, Norway

Medical University of Gdańsk

Gdansk, Poland

Medical University of Silesia

Katowice, Poland

Poznań University of Medical Sciences

Poznan, Poland

Provincial Hospital No. 2

Rzeszów, Poland

Clinical County Emergency Hospital

Sibiu, Romania

George Emil Palade University

Târgu Mureş, Romania

University and Polytechnic Hospital La Fe

Valencia, Spain