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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 28 days
Healthy Volunteers: f
View:

• newborn infants of any sex who are are having a thin catheter inserted into their trachea for the purpose of surfactant administration

Locations
Other Locations
Croatia
Clinical Hospital Centre
RECRUITING
Rijeka
Clinical Hospital Holy Spirit
RECRUITING
Zagreb
Greece
Aristotle University of Thessaloniki
RECRUITING
Thessaloniki
Hungary
Second Semmelweiss University
NOT_YET_RECRUITING
Budapest
Italy
University of Padova
NOT_YET_RECRUITING
Padua
Norway
Oslo University Hospital
RECRUITING
Oslo
Poland
Medical University of Gdańsk
RECRUITING
Gdansk
Medical University of Silesia
RECRUITING
Katowice
Poznań University of Medical Sciences
RECRUITING
Poznan
Provincial Hospital No. 2
RECRUITING
Rzeszów
Romania
Clinical County Emergency Hospital
RECRUITING
Sibiu
George Emil Palade University
RECRUITING
Târgu Mureş
Spain
University and Polytechnic Hospital La Fe
RECRUITING
Valencia
Contact Information
Primary
Colm P.F. O'Donnell, MB PhD
codonnell@nmh.ie
+35316373100
Backup
Janneke Dekker, PhD
j.dekker@lumc.nl
Time Frame
Start Date: 2025-01-13
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 600
Treatments
Video laryngoscopy used to insert thin endotracheal catheter
Video laryngoscopy used to insert thin endotracheal catheter
Direct laryngoscopy used to insert thin endotracheal catheter
Direct laryngoscopy used to insert thin endotracheal catheter
Related Therapeutic Areas
Sponsors
Leads: University College Dublin
Collaborators: Leiden University Medical Center

This content was sourced from clinicaltrials.gov