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

NCT06758492 | Recruiting

• 1 other identifier: NEU-VODEtec 01
• Study Type: observational
• Target: 600
• Locations: 9 countries
• Sites: 16

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.

Conditions

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

Keywords

infant, newborn; respiratory distress syndrome; surfactant; video laryngoscopy

Outcome Measures

Primary Outcomes (1)

• Successful thin catheter insertion at the first attempt without physiologic instability

  Successful thin catheter insertion at the first attempt without fall in SpO2 \>20% from baseline or HR\<100bpm

  At 30 minutes from the start of the insertion attempt

Secondary Outcomes (14)

• Successful thin catheter insertion at the first attempt

  At 30 minutes from the start of the insertion attempt

• Physiologic instability during first thin endotracheal catheter insertion attempt

  At 30 minutes from the start of the insertion attempt

• Duration of laryngoscopy of first insertion attempt

  At 30 minutes from the start of the insertion attempt

• Number of attempts taken to insert thin endotracheal catheter

  At 30 minutes from the start of the insertion attempt

• Time taken to insert thin endotracheal catheter on successful attempt

  At 30 minutes from the start of the insertion attempt

Study Arms (2)

Video laryngoscopy used to insert thin endotracheal catheter

Video laryngoscopy used to insert thin endotracheal catheter

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

Device: Direct laryngoscopy used to insert thin endotracheal catheter

Interventions

Video laryngoscopy used to insert thin endotracheal catheter DEVICE

Video laryngoscopy used to insert thin endotracheal catheter

Video laryngoscopy used to insert thin endotracheal catheter

Direct laryngoscopy used to insert thin endotracheal catheter DEVICE

Direct laryngoscopy used to insert thin endotracheal catheter

Direct laryngoscopy used to insert thin endotracheal catheter

Eligibility Criteria

• Age: 0 Minutes - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborn infants (\<28 days old) who have a thin catheter inserted into their trachea for the purpose of surfactant administration ("less-invasive surfactant administration", LISA)

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

Sponsors & Collaborators

• University College Dublin: lead
• Leiden University Medical Center: collaborator

Study Sites (16)

Clinical Hospital Centre

Rijeka, Croatia

RECRUITING

Clinical Hospital "Holy Spirit"

Zagreb, Croatia

RECRUITING

University Hospital Brno

Brno, Czechia

RECRUITING

General University Hospital

Prague, Czechia

RECRUITING

Institute for Mother and Child Care

Prague, Czechia

RECRUITING

Aristotle University of Thessaloniki

Thessaloniki, Greece

RECRUITING

Second Semmelweiss University

Budapest, Hungary

NOT YET RECRUITING

University of Padova

Padua, Italy

NOT YET RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

Medical University of Gdańsk

Gdansk, Poland

RECRUITING

Medical University of Silesia

Katowice, Poland

RECRUITING

Poznań University of Medical Sciences

Poznan, Poland

RECRUITING

Provincial Hospital No. 2

Rzeszów, Poland

RECRUITING

Clinical County Emergency Hospital

Sibiu, Romania

RECRUITING

George Emil Palade University

Târgu Mureş, Romania

RECRUITING

University and Polytechnic Hospital La Fe

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Atelectasis; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Colm P.F. O'Donnell, MB PhD

  National Maternity Hospital, Dublin, Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colm P.F. O'Donnell, MB PhD

CONTACT

+35316373100; codonnell@nmh.ie

Janneke Dekker, PhD

CONTACT

j.dekker@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 600 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 3, 2025
• Study Start: January 13, 2025
• Primary Completion: December 13, 2025
• Study Completion: December 31, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Study publication, for 2 years

Locations

CR (2); HU (1); IT (1); RO (2); CZ (3); GR (1); NO (1); PL (4); ES (1)