NCT02835209|Withdrawn
Study Stopped
Change in clinical practice that logistically prevented this study from being engaged.
Positioning During SBT in NICU Infants
Effect of Position on the Spontaneous Breathing Trial
Loading search results
Sponsor study identifier
observational
0
0 countries
N/A
Study Start
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Mechanical ventilation is a life-sustaining intervention in premature infants with respiratory difficulties. There is relative consensus when to intubate and provide positive pressure mechanical ventilation in the presence of respiratory failure. In contrast, discontinuation of mechanical ventilation during recovery remains largely subjective. A potential predictive tool for neonatal extubation is the Spontaneous Breathing Trial (SBT). The efficacy of SBT or other tests used in older patient populations in improving clinical judgment is questionable in the neonatal population with its unique physiology, respiratory mechanics and drive factors. Christiana Care Health System NICU currently uses the SBT as a standard part of neonatal assessment for extubation from mechanical ventilation. Infants in the CCHS NICU are routinely cared for in multiple positions (prone, supine, lateral) throughout the day. What is unknown is the impact of infant positioning on the SBT. An SBT performed in one position may not predict infant respiratory status after extubation in another position. Understanding the impact of infant positioning and work of breathing indices independently or in combination with an SBT will aid clinicians in decision-making and potentially decrease neonatal morbidity (inaccuracy with timing and safety of extubation). This pilot study will begin to explore these clinically relevant factors. Objectives: This pilot study will investigate the (1) role of infant position on SBT score and (2) the relationship of work of breathing indices in reference to the SBT score and infant position.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 8, 2016
Actual (reported)July 18, 2016
Actual (reported)November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Impact of infant positioning on spontaneous breathing test (SBT) pass rates
SBT will be performed with the infant in 3 different positions (supine, prone, side-lying).
Less than 1 hour
Impact of infant positioning on spontaneous breathing test (SBT) fail rates
SBT will be performed with the infant in 3 different positions (supine, prone, side-lying)
Less than 1 hour
WOB correlates of SBT pass rates
Less than 1 hour
WOB correlates of SBT fail rates
Less than 1 hour
Ventilated premature infants born 24 to 34+6 weeks gestational age.
Pulmonary function tests and work of breathing indices will be collected during the spontaneous breathing test.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Premature infants who are mechanically ventilated.
Robert Locke, DO, MPH
Christiana Care Health Services
0 participants (actual enrollment reported by the registry).
First Submitted
June 8, 2016
First Posted
July 18, 2016
Study Start
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A Study To InvestigateThe Safety, Tolerability And Efficacy Of Nebulised Curosurf® In Preterm Neonates With Respiratory Distress Syndrome (RDS)
Contact the study team to confirm eligibility.
Primary Completion
July 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 5, 2018
Record last verified: 2018-02
De-identified data would be shared in a data warehouse after a data use agreement was in place.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: