MedTrace Logo

A Pilot Study of Synchronized and Non-invasive Ventilation ("NeuroPAP") in Preterm Newborns

NCT02480205 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-01-31

No results posted yet for this study

Summary

There is currently a consensus that non-invasive ventilation (NIV) in preterm infants is preferred over intubation. There are two ways of delivering NIV in preterm infants, nasal continuous positive airway pressure (CPAP) or nasal intermittent positive pressure ventilation (NIPPV), where ventilator inflations are delivered intermittently over a fixed end-expiratory pressure. The synchronization in conventional mode is very difficult to obtain in premature infants. In all ventilation modes PEEP (end-expiratory pressure) is fixed. Considering that preterm infants are more likely to develop atelectasis, an active and ongoing management of the PEEP is very important to prevent de-recruitment.

A new respiratory support system (NeuroPAP) was developed to address these issues (synchronization problems and control the PEEP). It uses the electrical activity of the diaphragm (EDI) to control the ventilator assist continuously, both during inspiration (principle of NAVA mode) and also during expiration (based on tonic Edi level).

Conditions

Interventions

DEVICE

NeuroBox to deliver the NeuroPAP

The patients will be studied during the following conditions: * On conventional NIPPV device with the clinically prescribed settings (30 min) * With NeuroPAP and no change of Pmin (=peep) (60 min) * With NeuroPAP and adjusted Pmin (decreased by 2 cmH2O) (60 min) * During CPAP delivered with NeuroPAP device (15 min) * Again with original NIPPV device and settings for 30 minutes

Sponsors & Collaborators

  • Maquet Cardiovascular

    collaborator INDUSTRY

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Guillaume Emeriaud, MD, PhD · St. Justine's Hospital

  • Gregory Lodygensky, MD, PhD · St. Justine's Hospital

  • Jennifer Beck, PhD · Li Ka Shing Knowledge Institute. St. Michael's Hospital

  • Christer Sinderby, PhD · Li Ka Shing Knowledge Institute. St. Michael's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Days
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-01-30
Completion
2017-01-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02480205 on ClinicalTrials.gov