Using noninvasive ventilation during nasal intubation in newborns
The IntubAID Study - Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation
This study is testing if using noninvasive ventilation during nasal intubation helps newborns in the delivery room or neonatal intensive care unit be intubated successfully on the first try without any health issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zürich) |
| Trial ID | NCT06139809 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the quality of the local intubation protocol for newborns requiring endotracheal intubation in the delivery room or neonatal intensive care unit at the University Hospital Zurich. The primary focus is on achieving successful nasal intubation on the first attempt without causing physiological instability in the infants. Participants will undergo intubation using a standard procedure that incorporates non-invasive ventilation delivered through a nasopharyngeal tube. The outcomes will be compared to data from the SHINE-Trial conducted in Australia.
Who should consider this trial
Good fit: Ideal candidates include any neonate at the University Hospital Zurich who requires endotracheal intubation.
Not a fit: Patients requiring immediate intubation due to critical conditions or those with contraindications to non-invasive positive pressure ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the safety and effectiveness of intubation procedures in newborns.
How similar studies have performed: While this approach is being evaluated locally, similar studies have shown promise in improving intubation outcomes in neonatal care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any neonate at the Department of Neonatology of the University Hospital Zurich undergoing endotracheal intubation in the delivery room or neonatal intensive care unit. Exclusion Criteria: * Requirement for immediate endotracheal intubation as determined by the treating clinician, without time for potential application of NIPPV, e.g. active cardiopulmonary resuscitation. * Contraindication to NIPPV use (e.g. congenital diaphragmatic hernia, abdominal wall defects). * Oral intubation planned. * Denial of parental consent and/or inability of the parents to understand the study procedures due to cognitive or linguistic reasons. * Withdrawal at the discretion of the intubating clinician if he / she feels the study is interfering with a safe and optimal treatment of the patient.
Where this trial is running
Zürich
- University Hospital Zurich — Zürich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Christoph Rüegger, MD
- Email: christoph.rueegger@usz.ch
- Phone: +41 43 253 98 10
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.