Study Stopped
Computers/hardware for data collection/storage are outdated and unserviceable.
Pulmonary Function During Prone and Supine Positioning in NICU Infants Requiring Assisted Ventilation
1 other identifier
observational
N/A
1 country
1
Brief Summary
This study seeks to determine in Neonatal Intensive Care Unit (NICU) patients specific improvements in pulmonary function which may occur when an infant is ventilated in the prone as compared to the supine position. Modest improvement in oxygen has been reported to occur with prone positioning, but the exact etiology for this change is not clear. A special incubator designed as an integrated care system allows routine care and the measurement of both patient and ventilator breaths during mechanical ventilation. This study will utilize this device to evaluate in NICU ventilated patients whether specific changes in pulmonary function accompany position changes, and whether these are correlated to a change in pulmonary gas exchange.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2002
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 8, 2008
CompletedFirst Posted
Study publicly available on registry
September 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedMay 5, 2015
May 1, 2010
7.6 years
September 8, 2008
May 1, 2015
Conditions
Keywords
Eligibility Criteria
For stable NICU infants who require assisted mechanical ventilation beginning after the 1st 24 hours of life and repeating every 2 to 7 days
You may qualify if:
- Any NICU patient who does not have a major congenital anomaly and is on assisted mechanical ventilation will be eligible for this study.
You may not qualify if:
- Healthy patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah / Primary Childrens Medical Center
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald .Null, M.D.
University of Utah
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2008
First Posted
September 9, 2008
Study Start
October 1, 2002
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
May 5, 2015
Record last verified: 2010-05