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NCT01953562 Clinical Trial

Positioning and the Spontaneous Breathing Test in Neonates

Infants Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01953562
Other study ID # CCC#33186
Secondary ID
Status Withdrawn
Phase N/A
First received September 24, 2013
Last updated August 8, 2016
Start date October 2013
Est. completion date July 2014

Study information
Verified date August 2016
Source Christiana Care Health Services
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 6 Months
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Christiana Care Health Services

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary WOB indices during SBT Determination whether prone vs supine position alters the work of breathing indices in infants while receiving a SBT 10 minutes No
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