Actively Recruiting
Study Comparing Video and Direct Laryngoscopy for Inserting Thin Catheters Administering Surfactant to Newborn Babies with Breathing Difficulties
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 babys 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
Research Team
C
Colm P.F. O'Donnell, MB PhD
J
Janneke Dekker, PhD
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