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

NCT06757543 | Recruiting

• 1 other identifier: NEU-VODE 01
• Study Type: interventional
• Target: 840
• Locations: 10 countries
• Sites: 17

Brief 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

Keywords

infant, newborn; video laryngoscopy; intubation; stepped wedge cluster randomised trial

Outcome Measures

Primary Outcomes (1)

• Successful intubation at the first attempt without physiologic instability

  Successful intubation at the first attempt without physiologic instability where: 1. an intubation attempt is defined as the introduction of the laryngoscope blade into the mouth, whether or not an attempt is made to pass an endotracheal tube (ETT); 2. success is determined by detection of exhaled carbon dioxide (CO2) or with clinical signs (auscultation of breath sounds, condensation in the ETT); 3. physiologic instability is defined as a fall in oxygen saturation (SpO2) of \> 20% from the pre-attempt value or heart rate (HR) \< 100 beats per minute (bpm) during the attempt

  At 5 minutes from the start of the intubation attempt

Secondary Outcomes (10)

• Successful intubation at the first attempt

  At 5 minutes from the start of the intubation attempt

• Physiologic instability during the first intubation attempt

  At 5 minutes from the start of the intubation attempt

• Lowest SpO2 (%) measured with pulse oximetry during the procedure

  At 5 minutes from the start of the intubation attempt

• Lowest heart rate (HR) during the procedure

  At 5 minutes from the start of the intubation attempt

• Number of intubation attempts taken to intubate successfully

  At 30 minutes from the start of the intubation attempt

Study Arms (2)

Video laryngoscopy

EXPERIMENTAL

Participant intubated during period where first intubation attempt routinely made with video laryngoscope

Device: Video laryngoscopy

Direct laryngoscopy

ACTIVE COMPARATOR

Participant intubated during period where first intubation attempt routinely made with standard laryngoscope

Device: Direct laryngoscopy with standard laryngoscope

Interventions

Video laryngoscopy DEVICE

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

Video laryngoscopy

Direct laryngoscopy with standard laryngoscope DEVICE

Direct laryngoscopy with standard laryngoscope

Direct laryngoscopy

Eligibility Criteria

• Age: 0 Minutes - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Infants will be excluded if parents do not consent for their infants' data to be used.

Sponsors & Collaborators

• University College Dublin: lead
• National Maternity Hospital, Ireland: collaborator
• Leiden University Medical Center: collaborator

Study Sites (17)

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

RECRUITING

University of Padova

Padova, Italy

RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

Medical University of Gdańsk

Gdansk, Poland

RECRUITING

Medical University of Silesia

Katowice, Poland

RECRUITING

Provincial Hospital No. 2

Rzeszów, Poland

RECRUITING

Wrocław Medical University

Wroclaw, Poland

RECRUITING

Clinical County Emergency Hospital

Sibiu, Romania

RECRUITING

George Emil Palade University

Tărgu Mures, Romania

RECRUITING

University and Polytechnic Hospital La Fe

Valencia, Spain

RECRUITING

Bukovinian State Medical University

Chernivtsi, Ukraine

RECRUITING

Related Publications (5)

• Geraghty LE, Dunne EA, Ni Chathasaigh CM, Vellinga A, Adams NC, O'Currain EM, McCarthy LK, O'Donnell CPF. Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants. N Engl J Med. 2024 May 30;390(20):1885-1894. doi: 10.1056/NEJMoa2402785. Epub 2024 May 5.

  PMID: 38709215 RESULT

• Sawyer T, Foglia EE, Ades A, Moussa A, Napolitano N, Glass K, Johnston L, Jung P, Singh N, Quek BH, Barry J, Zenge J, DeMeo SD, Brei B, Krick J, Kim JH, Nadkarni V, Nishisaki A; National Emergency Airway Registry for Neonates (NEAR4NEOS) investigators. Incidence, impact and indicators of difficult intubations in the neonatal intensive care unit: a report from the National Emergency Airway Registry for Neonates. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F461-F466. doi: 10.1136/archdischild-2018-316336. Epub 2019 Feb 22.

  PMID: 30796059 RESULT

• Singh N, Sawyer T, Johnston LC, Herrick HM, Moussa A, Zenge J, Jung P, DeMeo S, Glass K, Howlett A, Shults J, Barry J, Brei BK, Kim JH, Quek BH, Tingay D, Mehrem AA, Napolitano N, Nishisaki A, Foglia EE; National Emergency Airway Registry for Neonates (NEAR4NEOS). Impact of multiple intubation attempts on adverse tracheal intubation associated events in neonates: a report from the NEAR4NEOS. J Perinatol. 2022 Sep;42(9):1221-1227. doi: 10.1038/s41372-022-01484-5. Epub 2022 Aug 18.

  PMID: 35982243 RESULT

• Foglia EE, Ades A, Sawyer T, Glass KM, Singh N, Jung P, Quek BH, Johnston LC, Barry J, Zenge J, Moussa A, Kim JH, DeMeo SD, Napolitano N, Nadkarni V, Nishisaki A; NEAR4NEOS Investigators. Neonatal Intubation Practice and Outcomes: An International Registry Study. Pediatrics. 2019 Jan;143(1):e20180902. doi: 10.1542/peds.2018-0902. Epub 2018 Dec 11.

  PMID: 30538147 RESULT

• American Academy of Pediatrics/American Heart Association. Textbook of Neonatal Resuscitation (8th ed, June 2021), editors Weiner GM, Zaichkin J. AAP, Elk Grove, IL USA.

  RESULT

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Colm P.F. O'Donnell, MB PhD

CONTACT

+35316373100; codonnell@nmh.ie

Janneke Dekker, PhD

CONTACT

+31715266620; j.dekker@lumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge cluster randomised study

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 3, 2025
• Study Start: January 13, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 2 years
• Access Criteria: Reasonable requests for IPD will be considered by the investigators

Locations

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