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

NCT06758492 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2025-02-20

No results posted yet for this 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.

Conditions

  • Respiratory Distress Syndrome (Neonatal)
  • Respiratory Distress Syndrome (RDS)
  • Video Laryngoscopy
  • Surfactant

Interventions

DEVICE

Video laryngoscopy used to insert thin endotracheal catheter

Video laryngoscopy used to insert thin endotracheal catheter

DEVICE

Direct laryngoscopy used to insert thin endotracheal catheter

Direct laryngoscopy used to insert thin endotracheal catheter

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • University College Dublin

    lead OTHER

Principal Investigators

  • Colm P.F. O'Donnell, MB PhD · National Maternity Hospital, Dublin, Ireland

Eligibility

Min Age
0 Minutes
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2025-12-13
Completion
2025-12-31

Countries

  • Croatia
  • Czechia
  • Greece
  • Hungary
  • Italy
  • Norway
  • Poland
  • Romania
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06758492 on ClinicalTrials.gov