NCT06758492 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College Dublin |
| Condition | Respiratory Distress Syndrome (Neonatal) |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2025-12-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2025-01-13 with a primary completion date of 2025-12-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Colm P.F. O'Donnell, MB PhD
PRINCIPAL INVESTIGATOR
National Maternity Hospital, Dublin, Ireland
Frequently Asked Questions
Who can join the NCT06758492 clinical trial?
This trial is open to participants of all sexes, aged 0 Minutes or older, up to 28 Days, studying Respiratory Distress Syndrome (Neonatal). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06758492 currently recruiting?
Yes, NCT06758492 is actively recruiting participants. Contact the research team at codonnell@nmh.ie for enrollment information.
Where is the NCT06758492 trial being conducted?
This trial is being conducted at Rijeka, Croatia, Zagreb, Croatia, Brno, Czechia, Prague, Czechia and 11 additional locations.
Who is sponsoring the NCT06758492 clinical trial?
NCT06758492 is sponsored by University College Dublin. The principal investigator is Colm P.F. O'Donnell, MB PhD at National Maternity Hospital, Dublin, Ireland. The trial plans to enroll 600 participants.