Actively Recruiting

Age: 0Minutes - 28Days
All Genders
ID06758492

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

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

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

Implementation

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

Long-term Monitoring

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

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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

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