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Search / Trial NCT06053684

Non-Invasive Ventilation Versus Neurally-Adjusted Ventilatory Assistance (NAVA) for the Treatment of Bronchiolitis

Launched by MONTEFIORE MEDICAL CENTER · Sep 18, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different breathing support methods for young children with bronchiolitis, a common respiratory condition. The researchers want to find out if a newer type of non-invasive ventilation called Neurally-Adjusted Ventilatory Assistance (NAVA) can help kids feel more comfortable and reduce the need for more serious treatments, like being put on a breathing machine (intubation). NAVA is designed to work more smoothly with a child's own breathing compared to the standard method, which may lead to better outcomes.

To participate in this study, children must be under two years old and diagnosed with bronchiolitis, and they will be monitored in a pediatric intensive care unit (ICU). However, children who have certain health conditions or are in critical condition may not be eligible. Families who join the trial can expect to receive either the NAVA method or the standard method of breathing support, and the research team will closely observe how well each method works. This study aims to improve care for young patients with respiratory issues and help doctors make better treatment choices in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients under the age of two years old with a diagnosis of bronchiolitis presenting to the pediatric ICU
  • Exclusion Criteria:
  • Patients unable to utilize a nasogastric tube
  • Patients with a diagnosis of chronic lung disease, cyanotic heart lesions, or congestive heart failure
  • Patients with hypotonia
  • Patients likely to require imminent intubation: \>0.60 Fraction of Inspired Oxygen (FiO2); Carbon Dioxide (CO2) \> 60, frequent apneas, clinician determines patient unlikely to tolerate non-invasive modality)
  • Patients with hemodynamic instability, defined as the need for vasoactive medication

About Montefiore Medical Center

Montefiore Medical Center is a leading academic medical institution located in the Bronx, New York, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a principal sponsor of clinical studies, Montefiore fosters a collaborative environment that connects researchers, healthcare professionals, and patients to explore cutting-edge therapies and improve health outcomes. With a strong emphasis on patient-centered care, the center integrates its extensive clinical expertise with robust research capabilities to address a wide range of medical conditions, contributing significantly to the advancement of medical science and clinical practice.

Locations

Bronx, New York, United States

Patients applied

0 patients applied

Trial Officials

Jacqueline Weingarten, MD

Principal Investigator

Physician

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported