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Intra-Abdominal Hypertension in Neonatal Intensive Care Patients

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00747552
First received: September 3, 2008
Last updated: January 22, 2010
Last verified: January 2010
History of Changes
Results First Received: July 21, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Intra-Abdominal Hypertension

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From Jan 2006 to Apr 2008, 32 infants who were inpatients in NICU were enrolled into the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 of the infants that were enrolled had the urinary catheter removed prior to any data collection. As the presence of a urinary catheter is necessary for bladder measurements, no data was able to be collected and therefore never actually started in the study.

Reporting Groups
  Description
Infants With Urinary Catheter in Place Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.

Participant Flow:   Overall Study
    Infants With Urinary Catheter in Place  
STARTED     30 [1]
COMPLETED     30  
NOT COMPLETED     0  
[1] This number does not include the 2 who were enrolled but had no data collected on them.



  Baseline Characteristics
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Reporting Groups
  Description
Infants With Urinary Catheter in Place Any infant admitted to the NICU who requires an indwelling urinary catheter as part of their illness will qualify for this study. This group will be further analyzed based on whether their illness is due to abdominal abnormalities or disease or whether there is another serious illness requiring an indwelling urinary catheter. The group will also be analyzed pre and post-operatively.

Baseline Measures
    Infants With Urinary Catheter in Place  
Number of Participants  
[units: participants]
 		  30  
Age  
[units: participants]
 		 
<=18 years     30  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     14  
Male     16  
Region of Enrollment  
[units: participants]
 		 
United States     30  



  Outcome Measures
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1.  Primary:   Intra-abdominal Pressure(IAP) Measurements in NICU Patients.   [ Time Frame: 3 years ]
  Show Outcome Measure 1

2.  Secondary:   Median Bladder Pressure for All Measurements   [ Time Frame: 3 years ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Donald Null M.D.
Organization: University of Utah
phone: 801.588-3865
e-mail: donald.null@imail.org


No publications provided


Responsible Party: Donald Null M.D., University of Utah
ClinicalTrials.gov Identifier: NCT00747552     History of Changes
Other Study ID Numbers: 13833
Study First Received: September 3, 2008
Results First Received: July 21, 2009
Last Updated: January 22, 2010
Health Authority: United States: Institutional Review Board