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Clinical Trials in Italy / NCT06758492
Recruiting Observational

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

NCT06758492 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-01-13
Last updated
2025-02-20

Condition(s) studied

Respiratory Distress Syndrome (Neonatal)Respiratory Distress Syndrome (RDS)Video LaryngoscopySurfactant

Investigational drug(s) / intervention(s)

Video laryngoscopy used to insert thin endotracheal catheterDirect laryngoscopy used to insert thin endotracheal catheter

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

Study 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

Sex
ALL
Min age
0 Minutes
Max age
28 Days
Healthy volunteers
No
Inclusion Criteria: * newborn infants of any sex who are are having a thin catheter inserted into their trachea for the purpose of surfactant administration Exclusion Criteria: * no parental consent provided to share their data

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Clinical Hospital Centre Rijeka Croatia Recruiting
Clinical Hospital "Holy Spirit" Zagreb Croatia Recruiting
University Hospital Brno Brno Czechia Recruiting
General University Hospital Prague Czechia Recruiting
Institute for Mother and Child Care Prague Czechia Recruiting
Aristotle University of Thessaloniki Thessaloniki Greece Recruiting
Second Semmelweiss University Budapest Hungary Not Yet Recruiting
University of Padova Padova Italy Not Yet Recruiting
Oslo University Hospital Oslo Norway Recruiting
Medical University of Gdańsk Gdansk Poland Recruiting
Medical University of Silesia Katowice Poland Recruiting
Poznań University of Medical Sciences Poznan Poland Recruiting
Provincial Hospital No. 2 Rzeszów Poland Recruiting
Clinical County Emergency Hospital Sibiu Romania Recruiting
George Emil Palade University Târgu Mureş Romania Recruiting
University and Polytechnic Hospital La Fe Valencia Spain Recruiting

More University College Dublin trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06758492 on ClinicalTrials.gov ↗ ← All trials in Italy