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

Recruiting now

Conditions studied: Respiratory Distress Syndrome (Neonatal), Respiratory Distress Syndrome (RDS), Video Laryngoscopy, Surfactant

In brief

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.

Key facts

Study ID

NCT06758492

Run by

University College Dublin

People needed

600

Starts

2025-01-13

Expected to finish

2025-12-31

Last updated by the study team

2025-02-20

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• no parental consent provided to share their data

Where it is running

• University and Polytechnic Hospital La Fe — Valencia, Spain (enrolling)
• Clinical Hospital "Holy Spirit" — Zagreb, Croatia (enrolling)
• University Hospital Brno — Brno, Czechia (enrolling)
• General University Hospital — Prague, Czechia (enrolling)
• Institute for Mother and Child Care — Prague, Czechia (enrolling)
• Aristotle University of Thessaloniki — Thessaloniki, Greece (enrolling)
• George Emil Palade University — Târgu Mureş, Romania (enrolling)
• Clinical Hospital Centre — Rijeka, Croatia (enrolling)
• Oslo University Hospital — Oslo, Norway (enrolling)
• Medical University of Gdańsk — Gdansk, Poland (enrolling)
• Medical University of Silesia — Katowice, Poland (enrolling)
• Poznań University of Medical Sciences — Poznan, Poland (enrolling)
• Provincial Hospital No. 2 — Rzeszów, Poland (enrolling)
• Clinical County Emergency Hospital — Sibiu, Romania (enrolling)
• Second Semmelweiss University — Budapest, Hungary
• University of Padova — Padova, Italy

Full record on ClinicalTrials.gov

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