Actively Recruiting

Age: 0Minutes - 28Days
All Genders
NCT06758492

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

Led by University College Dublin · Updated on 2025-02-20

600

Participants Needed

16

Research Sites

50 weeks

Total Duration

On this page

Sponsors

U

University College Dublin

Lead Sponsor

L

Leiden University Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Minutes - 28Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newborn infants of any sex who are having a thin catheter inserted into their trachea for surfactant administration
Not Eligible

You will not qualify if you...

  • No parental consent provided to share their data

AI-Screening

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Trial Site Locations

Total: 16 locations

1

Clinical Hospital Centre

Rijeka, Croatia

Actively Recruiting

2

Clinical Hospital "Holy Spirit"

Zagreb, Croatia

Actively Recruiting

3

University Hospital Brno

Brno, Czechia

Actively Recruiting

4

General University Hospital

Prague, Czechia

Actively Recruiting

5

Institute for Mother and Child Care

Prague, Czechia

Actively Recruiting

6

Aristotle University of Thessaloniki

Thessaloniki, Greece

Actively Recruiting

7

Second Semmelweiss University

Budapest, Hungary

Not Yet Recruiting

8

University of Padova

Padova, Italy

Not Yet Recruiting

9

Oslo University Hospital

Oslo, Norway

Actively Recruiting

10

Medical University of Gdańsk

Gdansk, Poland

Actively Recruiting

11

Medical University of Silesia

Katowice, Poland

Actively Recruiting

12

Poznań University of Medical Sciences

Poznan, Poland

Actively Recruiting

13

Provincial Hospital No. 2

Rzeszów, Poland

Actively Recruiting

14

Clinical County Emergency Hospital

Sibiu, Romania

Actively Recruiting

15

George Emil Palade University

Târgu Mureş, Romania

Actively Recruiting

16

University and Polytechnic Hospital La Fe

Valencia, Spain

Actively Recruiting

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Research Team

C

Colm P.F. O'Donnell, MB PhD

CONTACT

J

Janneke Dekker, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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