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Positioning and the Spontaneous Breathing Test in Neonates

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01953562
Enrollment
0
Registered
2013-10-01
Start date
2013-10-31
Completion date
2014-07-31
Last updated
2016-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infants, NICU, Spontaneous Breathing Test

Keywords

infants, NICU, intubated, ventilator

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).

Interventions

None listed

Sponsors

Christiana Care Health Services
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
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.

Design outcomes

Primary

MeasureTime frameDescription
Effect of prone vs supine positioning on whether an infant receives a passing score on the SBT test30 minutesSBT 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

MeasureTime frameDescription
WOB indices during SBT10 minutesDetermination whether prone vs supine position alters the work of breathing indices in infants while receiving a SBT

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026