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Pulmonary Function During Prone and Supine Positioning in NICU Infants Requiring Assisted Ventilation

This study has been withdrawn prior to enrollment.
(Computers/hardware for data collection/storage are outdated and unserviceable.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00749762
First Posted: September 9, 2008
Last Update Posted: May 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Utah
  Purpose
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.

Condition
Pulmonary Function

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pulmonary Function During Prone and Supine Positioning in Neonatal Intensive Care Unit (NICU) Infants Requiring Assisted Ventilation

Further study details as provided by University of Utah:

Enrollment: 0
Study Start Date: October 2002
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
For stable NICU infants who require assisted mechanical ventilation beginning after the 1st 24 hours of life and repeating every 2 to 7 days
Criteria

Inclusion Criteria:

  • Any NICU patient who does not have a major congenital anomaly and is on assisted mechanical ventilation will be eligible for this study.

Exclusion Criteria:

  • Healthy patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749762


Locations
United States, Utah
University of Utah / Primary Childrens Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Donald .Null, M.D. University of Utah
  More Information

Responsible Party: Donald Null M.D., University of Utah / Primary Childrens Medical Center
ClinicalTrials.gov Identifier: NCT00749762     History of Changes
Other Study ID Numbers: 10831
First Submitted: September 8, 2008
First Posted: September 9, 2008
Last Update Posted: May 5, 2015
Last Verified: May 2010

Keywords provided by University of Utah:
DURING
PRONE
SUPINE
POSITIONING