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

NCT ID: NCT06758492

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-13
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

Many newborn infants have breathing difficulty after birth, particularly when they are born prematurely. Many of these infants are supported with nasal continuous positive airway pressure (NCPAP). Some of the infants deteriorate despite treatment with NCPAP and have a thin catheter inserted into their trachea for the administration of surfactant, which is then immediately removed (often referred to as "less-invasive surfactant administration" or LISA). Insertion of a thin catheter is usually performed by doctors who are experienced at intubation (i.e. inserting endotracheal tubes, ETTs). They look directly into the the infants mouth using a standard laryngoscope to identify the opening of the airway (i.e. perform direct laryngoscopy). More recently video laryngoscopes have been developed. These devices display a magnified image of the airway on a screen that can be viewed indirectly by the doctor attempting to insert the ETT or thin catheter, and also by others. A single centre study reported that more infants were successfully intubated at the first attempt when doctors performed indirect video laryngoscopy compared to direct laryngoscopy.

It is possible to independently verify when a doctor has correctly inserted and ETT, for example by detecting carbon dioxide coming out of the tube or seeing condensation in the tube during exhalation, or by hearing breath sounds by listening to the chest during positive pressure inflations. It is not possible to independently verify whether a doctor has correctly inserted a thin catheter under direct laryngoscopy, by these or other means. The standard (and to date only) way of confirming that a thin catheter has been correctly inserted is to rely on the report of the operator. Video laryngoscopy, in contrast, allows the independent verification of the tip of a thin catheter by one or more people observing the screen.

The investigators are performing NEU-VODE, a stepped wedge cluster randomised study of the introduction of video laryngoscopy versus direct laryngoscopy for the intubation of newborn infants. Alongside this study, the investigators are performing a study of infants who have a thin endotracheal catheter inserted under video laryngoscopy versus direct laryngoscopy. As it is not possible to measure the outcome of successful insertion of the thin catheter equally in both groups, this is a prospective observational cohort study. The investigators will record information on infants who have a thin catheter inserted into the trachea for the purpose of surfactant administration at centres participating in the NEU-VODE study. The type of laryngoscope used for thin catheter insertion attempts will not be mandated; instead, the investigators will compare the information of groups within the cohort who have their first attempt made using the video laryngoscope to the group who have their first attempt made with direct laryngoscopy.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Video laryngoscopy used to insert thin endotracheal catheter

Video laryngoscopy used to insert thin endotracheal catheter

Video laryngoscopy used to insert thin endotracheal catheter

Intervention Type: DEVICE

Video laryngoscopy used to insert thin endotracheal catheter

Direct laryngoscopy used to insert thin endotracheal catheter

Direct laryngoscopy used to insert thin endotracheal catheter

Direct laryngoscopy used to insert thin endotracheal catheter

Intervention Type: DEVICE

Direct laryngoscopy used to insert thin endotracheal catheter

Interventions

Video laryngoscopy used to insert thin endotracheal catheter

Video laryngoscopy used to insert thin endotracheal catheter

Intervention Type: DEVICE

Direct laryngoscopy used to insert thin endotracheal catheter

Direct laryngoscopy used to insert thin endotracheal catheter

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Minutes
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

University College Dublin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colm P.F. O'Donnell, MB PhD

Role: PRINCIPAL_INVESTIGATOR

National Maternity Hospital, Dublin, Ireland

Locations

Clinical Hospital Centre

Rijeka, , Croatia

Site Status: RECRUITING

Clinical Hospital "Holy Spirit"

Zagreb, , Croatia

Site Status: RECRUITING

University Hospital Brno

Brno, , Czechia

Site Status: RECRUITING

General University Hospital

Prague, , Czechia

Site Status: RECRUITING

Institute for Mother and Child Care

Prague, , Czechia

Site Status: RECRUITING

Aristotle University of Thessaloniki

Thessaloniki, , Greece

Site Status: RECRUITING

Second Semmelweiss University

Budapest, , Hungary

Site Status: NOT_YET_RECRUITING

University of Padova

Padua, , Italy

Site Status: NOT_YET_RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status: RECRUITING

Medical University of Gdańsk

Gdansk, , Poland

Site Status: RECRUITING

Medical University of Silesia

Katowice, , Poland

Site Status: RECRUITING

Poznań University of Medical Sciences

Poznan, , Poland

Site Status: RECRUITING

Provincial Hospital No. 2

Rzeszów, , Poland

Site Status: RECRUITING

Clinical County Emergency Hospital

Sibiu, , Romania

Site Status: RECRUITING

George Emil Palade University

Târgu Mureş, , Romania

Site Status: RECRUITING

University and Polytechnic Hospital La Fe

Valencia, , Spain

Site Status: RECRUITING

Countries

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

Central Contacts

Colm P.F. O'Donnell, MB PhD

Role: CONTACT

codonnell@nmh.ie

+35316373100

Janneke Dekker, PhD

Role: CONTACT

j.dekker@lumc.nl

Facility Contacts

Iva Bilić Čače, MD PhD

Role: primary

Rebeka Ribičić, MD

Role: primary

Andrea Stanikova, MD

Role: primary

Tereza Lamberská, MD PhD

Role: primary

Milena Tušková, MD

Role: primary

Kosmas Sarafidis, MD

Role: primary

Zsuzsanna Nagy, MD

Role: primary

Daniele Trevisanuto, MD PhD

Role: primary

Anne Lee Solevåg, MD PhD

Role: primary

Joanna Jassem-Bobowicz, MD

Role: primary

Iwona Chudek Maruniak, MD

Role: primary

Tomasz Szczapa, MD PhD

Role: primary

Witold Blaz, MD

Role: primary

Maria Livia Ognean, MD PhD

Role: primary

Manuela Curcerea, MD PhD

Role: primary

Raquel Escrig Fernández, MD PhD

Role: primary

Other Identifiers

NEU-VODEtec 01

Identifier Type: -

Identifier Source: org_study_id