A Stepped Wedge Cluster Randomised Trial of Video Versus Direct Laryngoscopy for Intubation of Newborn Infants

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 1 month
Healthy Volunteers: f
View:

• Infants of any gestational age in whom endotracheal intubation is attempted can be included in this study once there is parental consent to the use their infant's data.

Locations
Other Locations
Croatia
Clinical Hospital Centre
RECRUITING
Rijeka
Clinical Hospital Holy Spirit
RECRUITING
Zagreb
Greece
Aristotle University of Thessaloniki
RECRUITING
Thessaloniki
Hungary
Second Semmelweiss University
NOT_YET_RECRUITING
Budapest
Italy
University of Padova
NOT_YET_RECRUITING
Padua
Norway
Oslo University Hospital
RECRUITING
Oslo
Poland
Medical University of Gdańsk
RECRUITING
Gdansk
Medical University of Silesia
RECRUITING
Katowice
Poznań University of Medical Sciences
RECRUITING
Poznan
Provincial Hospital No. 2
RECRUITING
Rzeszów
Wrocław Medical University
RECRUITING
Wroclaw
Romania
Clinical County Emergency Hospital
RECRUITING
Sibiu
George Emil Palade University
RECRUITING
Tărgu Mures
Spain
University and Polytechnic Hospital La Fe
RECRUITING
Valencia
Ukraine
Bukovinian State Medical University
RECRUITING
Chernivtsi
Contact Information
Primary
Colm P.F. O'Donnell, MB PhD
codonnell@nmh.ie
+35316373100
Backup
Janneke Dekker, PhD
j.dekker@lumc.nl
+31715266620
Time Frame
Start Date: 2025-01-13
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 840
Treatments
Experimental: Video laryngoscopy
Participant intubated during period where first intubation attempt routinely made with video laryngoscope
Active_comparator: Direct laryngoscopy
Participant intubated during period where first intubation attempt routinely made with standard laryngoscope
Related Therapeutic Areas
Sponsors
Leads: University College Dublin
Collaborators: National Maternity Hospital, Ireland, Leiden University Medical Center

This content was sourced from clinicaltrials.gov