Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Newborn infants of any sex who are having a thin catheter inserted into their trachea for surfactant administration
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
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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