Noninvasive Positive Pressure Ventilation During Neonatal Nasal Intubation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2025-10-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to perform a quality control assessment of our local intubation protocol in any newborn infant requiring endotracheal intubation in the delivery room or neonatal intensive care unit at the Department of Neonatology of the University Hospital Zurich. The primary aims are:

* Successful nasal intubation at the first attempt without physiological instability.
* Comparison of infants with successful intubation at the first attempt without physiological instability to the infants in the SHINE-Trial in Australia.

Participants will be intubated according to our standard intubation procedure using non-invasive ventilation (NIV) delivered through a nasopharyngeal tube.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates

NCT04089540

Intubation; Difficult or Failed Preterm Infant Term Infant

COMPLETED NA

Optimizing Tracheal Intubation Outcomes and Neonatal Safety

NCT05838690

Infant Intubation Complication

RECRUITING NA

Feasibility and Reliability of Synchronized Non-invasive Intermittent Positive Pressure Ventilation in Preterm Infants After Birth

NCT05399914

Preterm Infant Delivery Room Respiratory Support +1 more

COMPLETED

Nasal Intermittent Positive Pressure Ventilation During Neonatal Intubation

NCT06549283

Respiratory Distress Syndrome Intubation; Difficult or Failed Newborn Morbidity +2 more

COMPLETED NA

Evaluating Pressures During Non-invasive Ventilation Utilizing NIV Plus Software

NCT05961683

Respiratory Distress Syndrome, Newborn Apnea of Newborn

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant, Newborn, Diseases Intubation Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective single-center study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intubation

Intubation will take place according to our local standard protocol for nasal intubation using non-invasive positive pressure ventilation (NIPPV) delivered through a nasopharyngeal tube. The intubation will be video-recorded to provide a clear view of the procedure and the pulse oximeter displaying the peripheral oxygen saturation (SpO2 \[%\]) and heart rate (HR \[bpm\]).

Group Type OTHER

Intubation

Intervention Type PROCEDURE

Intubation will take place according to our local standard protocol for nasal intubation using NIPPV delivered through a nasopharyngeal tube. The intubation will be video-recorded to provide a clear view of the procedure and the pulse oximeter displaying the SpO2 and HR.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intubation

Intubation will take place according to our local standard protocol for nasal intubation using NIPPV delivered through a nasopharyngeal tube. The intubation will be video-recorded to provide a clear view of the procedure and the pulse oximeter displaying the SpO2 and HR.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes