NCT00368485

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

September 21, 2011

Status Verified

September 1, 2011

Enrollment Period

1.8 years

First QC Date

August 22, 2006

Last Update Submit

September 19, 2011

Conditions

Respiratory Distress Syndrome, NewbornInfant, Premature

Keywords

diaphragm electrical activitynon invasive ventilationpatient ventilator interaction

Outcome Measures

Primary Outcomes (1)

  • patient ventilator interaction

    20 minutes

Secondary Outcomes (2)

  • breathing pattern

    20 min

  • diaphragm activity

    20 min

Interventions

Neurally Controlled Mechanical VentilationDEVICE

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

Eligibility Criteria

Age1 Week - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Part 1: Preterm newborns (\>1 week postnatal age, gestational age\> 23 weeks, birth weight \<1000g), intubated and mechanically ventilated, and breathing spontaneously. Infants should be breathing on a triggered mode of ventilation (SIMV, assist control, or pressure support) with the following ventilator parameters: assist control/pressure support \< 20 cm H2O, PEEP4-7 cm H2O, SIMV rate\< 30, FIO2\<40%/.
  • Part 2:Newborns recovering from respiratory illness and deemed to be ready for elective extubation by their attending physician, intubated and mechanically ventilated, and breathing spontaneously.

You may not qualify if:

  • Protocols 1 and 2: Pneumothorax, degenerative neuromuscular disease, bleeding disorders, cardiovascular instability (defined as hypotension or need for treatment with volume expansion or inotropes in the previous 24 hours), cyanotic congenital cardiovascular disease, treatment with narcotics, phrenic nerve damage/diaphragm paralysis, esophageal perforation, use of high frequency oscillatory ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M5S1B6, Canada

Location

Related Publications (1)

  • Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. doi: 10.1038/71012. No abstract available.

    PMID: 10581089BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornPremature Birth

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Christer Sinderby, PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

  • Michael S Dunn, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Arthur Slutsky, MD

    Unity Health Toronto

    STUDY DIRECTOR

  • Jennifer Beck, PhD

    Sunnybrook Health Sciences Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Scientist

Study Record Dates

First Submitted

August 22, 2006

First Posted

August 24, 2006

Study Start

August 1, 2006

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

September 21, 2011

Record last verified: 2011-09

Locations

CA(1)