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Neural Control of Non-invasive Ventilation in the Preterm

NCT00368485 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-09-21

No results posted yet for this study

Summary

The present study will use a new type of respirator in premature babies who need help with their breathing. This new respirator uses signals from the baby's diaphragm - the most important breathing muscle - to control the timing and the amount of air that the baby needs. The goal of the study is to demonstrate that this new respirator can synchronize delivery of air to the baby's efforts, and that synchrony is maintained regardless of whether the baby is breathing with a tube or a mask.

Conditions

  • Respiratory Distress Syndrome, Newborn
  • Infant, Premature

Interventions

DEVICE

Neurally Controlled Mechanical Ventilation

A new mode of mechanical ventilation controlled by the electrical activity of the diaphragm (NAVA) will be used before and after extubation.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Christer Sinderby, PhD · Unity Health Toronto

  • Michael S Dunn, MD · Sunnybrook Health Sciences Centre

  • Arthur Slutsky, MD · Unity Health Toronto

  • Jennifer Beck, PhD · Sunnybrook Health Sciences Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Week
Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Canada

Study Locations

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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 NCT00368485 on ClinicalTrials.gov