- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01953562
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:
- work of breathing indices: obtained non-invasively through respiratory inductive plethysmography (RIP).
- 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Withdrawn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
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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