Comparing video laryngoscopy and direct laryngoscopy for surfactant administration in newborns
A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants
This study is testing whether using video laryngoscopy makes it easier to insert a breathing tube for surfactant treatment in newborns with breathing problems compared to the standard method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 0 Minutes to 28 Days |
| Sex | All |
| Sponsor | University College Dublin Academic / other |
| Locations | 16 sites (Rijeka and 15 other locations) |
| Trial ID | NCT06758492 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the effectiveness of video laryngoscopy versus direct laryngoscopy for the insertion of a thin endotracheal catheter in newborn infants requiring surfactant administration due to respiratory distress syndrome. The study will involve newborns who are experiencing breathing difficulties and require a thin catheter for surfactant delivery. By utilizing video laryngoscopy, which provides a magnified view of the airway, the study seeks to determine if this method improves the success rate of catheter insertion compared to the traditional direct laryngoscopy approach. Data will be collected from multiple clinical sites to assess outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are newborn infants of any sex who require a thin catheter for surfactant administration.
Not a fit: Patients who do not have parental consent to share their data will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the success rates of surfactant administration in newborns, leading to better respiratory outcomes.
How similar studies have performed: Previous studies have shown that video laryngoscopy may improve intubation success rates, suggesting potential benefits for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rijeka and 15 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 (Not_yet_recruiting)
- University of Padova — Padova, 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)
Study contacts
- Principal investigator: Colm P.F. O'Donnell, MB PhD — National Maternity Hospital, Dublin, Ireland
- 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.