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Positioning and the Spontaneous Breathing Test in Neonates

Sponsor
Christiana Care Health Services (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01953562
Collaborator
(none)
0
Enrollment
9
Duration (Months)

Study Details

Study Description

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. 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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of the Influence of Positioning and Time Duration on the Spontaneous Breathing Test in Neonates
    Study Start Date :
    Oct 1, 2013
    Actual Primary Completion Date :
    Jul 1, 2014
    Actual Study Completion Date :
    Jul 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Intubated infants

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. WOB indices during SBT [10 minutes]

      Determination whether prone vs supine position alters the work of breathing indices in infants while receiving a SBT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 6 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Christiana Care Health Services

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert Locke, Neonatologist, Christiana Care Health Services
    ClinicalTrials.gov Identifier:
    NCT01953562
    Other Study ID Numbers:
    • CCC#33186
    First Posted:
    Oct 1, 2013
    Last Update Posted:
    Aug 9, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by Robert Locke, Neonatologist, Christiana Care Health Services
    infants
    NICU
    intubated
    ventilator
    Additional relevant MeSH terms:
    Respiratory Aspiration

    Study Results

    No Results Posted as of Aug 9, 2016