NCT02048280

Brief Summary

Neurally adjusted ventilatory assist (NAVA) is a mode of mechanical ventilation that uses the diaphragm's normal electrical activity to deliver a mechanically supported breath. The amount of support provided is determined in part by the NAVA level, where a higher NAVA level will provide higher level of support and unload more of the work of the diaphragm. The purpose of this study is to compare the optimal NAVA level in neonates while on mechanical ventilation while intubated and after being extubated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

January 13, 2014

Last Update Submit

July 29, 2015

Conditions

Other Specified Respiratory Problems in Fetus or Neonate

Outcome Measures

Primary Outcomes (1)

  • Changes in breakpoint in intubated and extubated patients

    NAVA titration study will be done pre and post extubation to determine and then compare the breakpoint.

    20 minute study pre and post extubation

Study Arms (1)

Intubated

EXPERIMENTAL

NAVA level from 0.1 to 3

Procedure: NAVA levelOther: NAVA level

Interventions

NAVA levelPROCEDURE

Peak inspiratory pressure will be measured at each NAVA level

Intubated

Eligibility Criteria

Age23 Weeks - 40 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Neonates on NAVA ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Promedica Toledo CHildren's Hospital NICU

Toledo, Ohio, 43606, United States

Location

Study Officials

  • Howard Stein, MD

    Promedica Toledo Childrne's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 29, 2014

Study Start

December 1, 2012

Primary Completion

June 1, 2014

Study Completion

April 1, 2015

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations

US(1)