Positioning and the Spontaneous Breathing Test in Neonates

NCT ID: NCT01953562

Last Updated: 2016-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-07-31

Brief Summary

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

Detailed Description

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Conditions

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Spontaneous Breathing Test Infants NICU

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intubated infants

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christiana Care Health Services

OTHER

Sponsor Role lead

Responsible Party

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Robert Locke

Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Locke, DO, MPH

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Other Identifiers

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CCC#33186

Identifier Type: -

Identifier Source: org_study_id

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