Clinical Trials Logo
  1. Home
  2. Pediatric Respiratory Diseases
  3. NCT03650478

Assessment of NeuroBOX and NeuroPAP in Infants. — NeuroPap2  

Bronchiolitis Clinical Trial

Official title:
Clinical Assessment of the NeuroBOX, a Cardio-respiratory Monitor Combined With a Fully Neurally Controlled Non-invasive Ventilator, in Infants.

Clinical Trial Summary

Non-invasive ventilation (NIV, delivered via a mask or cannulas) permits to reduce the need for tracheal intubation in infants who needs a ventilatory support. NIV can be delivered with nasal CPAP (continuous positive airway pressure) or NIPPV (nasal intermittent positive pressure ventilation). The synchronization of the respiratory support according to the patient's demand is very difficult to obtain in infants with the conventional ventilatory modes. In all these ventilatory modes, the end-expiratory pressure (PEEP) is fixed and set by the clinician. However, since infants are prone to alveolar collapse and must compensate for a non-compliant chest wall, an active and ongoing management of PEEP is very important to prevent the lung de-recruitment. A new respiratory support system (NeuroPAP) has been developed to address these issues of synchronization and control of PEEP. This new system uses diaphragmatic tonic activity (Edi) that reflects the patient's efforts to increase lung recruitment and therefore it continuously controls the delivery of assist continuously both during inspiration (like NAVA) and during expiration, allowing a unique neural control of PEEP. A new device, the NeuroBOX, permits to deliver NIV with NeuroPAP, CPAP, or NIPPV, and also to serve as a cardio-respiratory monitor, tracking and displaying cardiac and respiratory signals, trends, and cardio-vascular events. The two main objectives of this study are: 1- To evaluate the clinical impact of NeuroPAP in infants with high tonic Edi; 2- To characterize the cardio-respiratory pattern and its relationship with cerebral perfusion of infants with noninvasive support, using the monitoring capacity of the NeuroBOX. The investigators expect that NeuroPAP will permit to improve the efficiency of NIV in infants, through the better synchronization and the personalization of the expiratory pressure level in response to the patient needs. This study will be conducted in two subgroups of patients at high risk of elevated tonic Edi and of cardio-respiratory events: a subgroup of premature infants and a subgroup of infants with bronchiolitis.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03650478
Study type Interventional
Source St. Justine's Hospital
Contact
Status Completed
Phase N/A
Start date October 1, 2018
Completion date October 31, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04989114 - Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Children With Bronchiolitis N/A
Recruiting NCT06016244 - Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial N/A
Not yet recruiting NCT05902702 - Isotonic Saline for Children With Bronchiolitis N/A
Recruiting NCT02366715 - Treatment Of Bronchiolitis With Heated Humidified High Flow Nasal Cannula - Prospective And Retrospective Research Phase 3
Terminated NCT02219334 - Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study N/A
Recruiting NCT01944995 - Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis N/A
Terminated NCT02834819 - Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis N/A
Terminated NCT01757496 - Cough Assist in Bronchiolitis N/A
Not yet recruiting NCT01414322 - Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients N/A
Completed NCT00369759 - An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants N/A
Completed NCT00347880 - Atrial and Brain Natriuretic Peptides in Bronchiolitis Phase 1
Recruiting NCT05548036 - A Feasibility RCT of Aerobika Verses ACBT in People With COPD N/A
Active, not recruiting NCT04302207 - The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study N/A
Completed NCT02858531 - Predictive Tracking of Patient Flow in the Emergency Services During the Virus Winter Epidemics
Withdrawn NCT05994183 - The Bronchiolitis in Hospitalized Infants Study Early Phase 1
Terminated NCT03614507 - Automation Oxygen Flow Titration in Spontaneously Breathing Infants N/A
Completed NCT02856165 - High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis N/A
Recruiting NCT05909566 - Respiratory Support and Treatment for Efficient and Cost-Effective Care N/A
Recruiting NCT04437641 - Impact of Pediatrician Intervention on the Smoking Habits of Parents of Sick Children
Not yet recruiting NCT06083077 - Chest and Abdominal Wall Strapping in Infant With Bronchiolitis N/A