Comparing video and direct laryngoscopy for intubating newborns
A Stepped Wedge Cluster Randomised Trial Of Video Versus Direct Laryngoscopy For Intubation Of Newborn Infants
This study tests whether using video laryngoscopy or direct laryngoscopy is better for helping newborns who need breathing support through intubation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 840 (estimated) |
| Ages | 0 Minutes to 1 Month |
| Sex | All |
| Sponsor | University College Dublin Academic / other |
| Locations | 17 sites (Rijeka and 16 other locations) |
| Trial ID | NCT06757543 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of video laryngoscopy versus direct laryngoscopy for intubating newborn infants who require breathing support. The study will utilize a stepped wedge cluster randomised design, allowing for a systematic evaluation of both techniques across multiple hospitals. By assessing the success rates of intubation attempts and associated complications, the trial seeks to determine which method provides better outcomes for infants in need of intubation. The study will include infants of any gestational age, provided parental consent is obtained for data usage.
Who should consider this trial
Good fit: Ideal candidates for this study are newborn infants of any gestational age who require endotracheal intubation.
Not a fit: Patients whose parents do not consent to the use of their infant's data will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved intubation success rates and reduced complications for newborns requiring respiratory support.
How similar studies have performed: Previous studies have shown that video laryngoscopy can improve intubation success rates compared to direct laryngoscopy, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Infants will be excluded if parents do not consent for their infants' data to be used.
Where this trial is running
Rijeka and 16 other locations
- 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)
Study contacts
- Study coordinator: Colm P.F. O'Donnell, MB PhD
- Email: codonnell@nmh.ie
- Phone: +35316373100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.