Actively Recruiting
Prospective Observational Study Comparing Video Laryngoscopy Versus Direct Laryngoscopy for Thin Endotracheal Catheter Insertion in Newborn Infants Needing Surfactant
Led by University College Dublin · Updated on 2025-02-20
600
Participants Needed
16
Research Sites
2 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 newborns have trouble breathing after birth and receive support with a breathing machine called nasal continuous positive airway pressure (NCPAP). When their breathing worsens despite NCPAP, they may be treated with surfactant medication inserted into the windpipe using either a ventilation tube or a thin catheter. This research is studying the use of video laryngoscopes, which have a camera and display the airway on a screen, compared to standard direct laryngoscopes that require doctors to look directly into the baby's mouth to insert the tube or catheter. The study aims to see if video laryngoscopy improves the success rate of inserting the thin catheter on the first attempt without causing drops in oxygen or heart rate. The study observes infants who need a thin endotracheal catheter inserted for surfactant administration. It compares two approaches: using a video laryngoscope versus a direct laryngoscope during the insertion. This is done across multiple hospitals, each switching from direct to video laryngoscopy over time. The study does not assign which method is used but records which laryngoscope was used for each insertion attempt to compare outcomes. The main focus is on successful first attempts without physiologic instability, as well as secondary measures like number of attempts, duration, oxygen levels, heart rate, and any complications. Participants are newborn infants up to 28 days old who require thin catheter insertion for surfactant treatment and whose parents have consented to share data. Researchers will collect detailed information during and after the insertion attempt, including heart rate, oxygen saturation, duration of the procedure, and any adverse events such as oral trauma or need for chest compressions. Data will be analyzed to evaluate the success and safety of using video versus direct laryngoscopy. The total participation time depends on when the catheter insertion is performed and the follow-up assessments within 72 hours after the procedure.
CONDITIONS
Brief 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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to confirm eligibility before the procedure
Duration - Procedure and immediate assessment lasting up to 1 hour
Participants have a thin endotracheal catheter inserted using either video laryngoscopy or direct laryngoscopy for surfactant administration.
1 procedure visit and monitoring during the procedure
Duration - Up to 72 hours after catheter insertion attempt
Participants are observed for outcomes related to the catheter insertion and surfactant treatment, including respiratory support and complications.
Follow-up observations and assessments up to 72 hours after the procedure
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
J
Janneke Dekker, PhD
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