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

This study has been terminated.
(Computers/hardware for data collection/storage are outdated and unserviceable.)
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00749762
First received: September 8, 2008
Last updated: May 17, 2010
Last verified: May 2010
  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

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 8, 2008
Last Updated: May 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
DURING
PRONE
SUPINE
POSITIONING

ClinicalTrials.gov processed this record on April 15, 2014