NCT01953562

Brief Summary

The spontaneous breathing test (SBT) is routinely performed on all intubated patients in the NICU who are potential candidates for extubation from mechanical ventilatory support. For all parents who consent, the routine SBT will be performed on all infants. In addition to the routine SBT the following will occur:

  1. 1.work of breathing indices: obtained non-invasively through respiratory inductive plethysmography (RIP).
  2. 2.Performing the SBT in the prone position, in addition to the routine position (supine).

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Status
withdrawn

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

First Submitted

Initial submission to the registry

September 24, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

9 months

First QC Date

September 24, 2013

Last Update Submit

August 8, 2016

Conditions

Spontaneous Breathing TestInfantsNICU

Keywords

infantsNICUintubatedventilator

Outcome Measures

Primary Outcomes (1)

  • Effect of prone vs supine positioning on whether an infant receives a passing score on the SBT test

    SBT is a pass/fail test. The effect of prone vs supine positioning in intubated neonates on whether a spontaneous breathing test is scored pass or fail will be determined.

    30 minutes

Secondary Outcomes (1)

  • WOB indices during SBT

    10 minutes

Study Arms (1)

Intubated infants

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Intubated infants who qualify for the routine spontaneous breathing test.

You may qualify if:

  • Infants who qualify for SBT as part of their normal care

You may not qualify if:

  • Previous history of abdominal or chest surgery (i.e. chest tube, PDA ligation, surgical NEC)
  • Congenital malformation of the chest of abdomen
  • Neuromuscular disorder
  • Current medications affecting neuromuscular tone (ex morphine)
  • Unable to be positioned either prone or supine as determined by the attending neonatologist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Robert Locke, DO, MPH

    Christiana Care Health Services

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neonatologist

Study Record Dates

First Submitted

September 24, 2013

First Posted

October 1, 2013

Study Start

October 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 9, 2016

Record last verified: 2016-08