Positioning and the Spontaneous Breathing Test in Neonates

August 8, 2016 updated by: Robert Locke, Christiana Care Health Services

Evaluation of the Influence of Positioning and Time Duration on the Spontaneous Breathing Test in Neonates

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).

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Intubated infants who qualify for the routine spontaneous breathing test.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intubated infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of prone vs supine positioning on whether an infant receives a passing score on the SBT test
Time Frame: 30 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOB indices during SBT
Time Frame: 10 minutes
Determination whether prone vs supine position alters the work of breathing indices in infants while receiving a SBT
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christiana Care Health Services

Investigators

  • Principal Investigator: Robert Locke, DO, MPH, Christiana Care Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 24, 2013

First Submitted That Met QC Criteria

September 26, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCC#33186

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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