A Stepped Wedge Cluster Randomised Trial Of Video Versus Direct Laryngoscopy For Intubation Of Newborn Infants

Summary

Many newborn babies have difficulty breathing. When babies need a lot of help, a doctor will intubate them - i.e. put a tube into their windpipe (trachea) - so that they can be given support with a breathing machine. Intubation is a difficult procedure, during which many babies have falls in their blood oxygen levels and heart rate. When doctors intubate babies, they use a device called a laryngoscope to identify the entrance to the windpipe. A standard laryngoscope has a light at its tip. When doctors use this device, they insert it into the baby's mouth and then look directly into the mouth to find the entrance (direct laryngoscopy). Less than half of first attempts to insert a tube are successful using this device. More recently, video laryngoscopes have been developed. These devices also have a camera at the tip and display a magnified view of the entrance to the windpipe on a screen. A study at one hospital showed that the doctors there inserted the tube at the first attempt more often when they used a video laryngoscope instead of a standard laryngoscope. This study was not large enough to see whether fewer babies had low oxygen levels or heart rate during the procedure.

The goal of this clinical trial is to see whether more newborn babies are intubated at the first attempt without falls in their blood oxygen levels or heart rate when the doctors use video laryngoscopy compared to direct laryngoscopy.

Hospitals where doctors routinely intubate babies by looking directly into the mouth will take part in the NEU-VODE study. From the start of the study, the doctors at each hospital will continue with their usual approach to intubation and collect information about intubation attempts. As the study progresses, the doctors at each participating hospital will switch one--by-one to routinely attempting intubation with a video laryngoscope. The date on which they switch will be determined by chance. By the end of the study, each hospital will have had a study period where babies were routinely intubated using direct laryngoscopy and video laryngoscopy.

At the end of the study, the information collected from all the babies intubated during the study will be compared to see if more babies were successfully intubated at the first attempt without falls in their blood oxygen levels or heart rate in the video laryngoscopy group.

Conditions

• Intubation
• Intubation Complications
• Infant, Newborn
• Infant Respiratory Distress Syndrome
• Video Laryngoscopy

Interventions

DEVICE

Video laryngoscopy

Video laryngoscopy with C-MAC (Karl Storz, Tuttlingen, Germany)

DEVICE

Direct laryngoscopy with standard laryngoscope

Direct laryngoscopy with standard laryngoscope

Sponsors & Collaborators

• National Maternity Hospital, Ireland

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• University College Dublin

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Minutes

Max Age

1 Month

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-13

Primary Completion

2026-08-15

Completion

2026-08-31

Countries

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

Study Locations