Positioning and the Spontaneous Breathing Test in Neonates | NCT01953562

Studies
Positioning and the Spontaneous Breathing Test in Neonates

NCT01953562

Sponsor

Christiana Care Health Services

Status

Withdrawn

Last Update Posted

Aug 9, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Spontaneous Breathing Test
Infants
NICU

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This protocol was closed and will be redesigned and submitted as a new protocol.

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Sep 24, 2013

First Submission Date that Met QC Criteria

Sep 26, 2013

First Posted Date

Oct 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2016

Last Update Posted Date

Aug 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Intubated infants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Months

Standard Ages

Child

Study Population

Intubated infants who qualify for the routine spontaneous breathing test.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Locke, DO, MPH	Christiana Care Health Services	Principal Investigator

Locations

Not provided