Intra-Abdominal Hypertension in Neonatal Intensive Care Patients

NCT00747552 | Completed Results

• 1 other identifier: 13833
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The observational study is designed to determine the feasibility of performing Intra-Abdominal Pressure (IAP) via bladder pressure measurements and of tracking IAP in neonates who require bladder catheterization. Correlation of IAP measurements with clinical status of the neonatal abdomen will help determine threshold values for Intra-Abdominal Hypertension (IAH) in the neonate.

Conditions

Intra-Abdominal Hypertension

Keywords

IAP measurements; Abdominal compartment syndrome; NICU patients; Intra-abdominal Hypertension

Outcome Measures

Primary Outcomes (1)

• Intra-abdominal Pressure(IAP) Measurements in NICU Patients.

  Intra-abdominal Pressure (IAP) measurements were taken using an electronic pressure transducer via an indwelling urinary catheter. Measurements were obtained every 2-4 hours while the urinary catheter remained in place. This will be used to determine feasability of using a urinary catheter and electronic pressure transducer system to determine IAP. A total of 1219 measurements were obtained from 30 subjects.

  3 years

Secondary Outcomes (1)

• Median Bladder Pressure for All Measurements

  3 years

Eligibility Criteria

• Age: Up to 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective observational study. A convenience sample of 50 NICU patients will be planned to be enrolled at Primary Children's Medical Center and/or the University of Utah Hospital.

You may not qualify if:

• Bladder trauma
• History of recent bladder surgery
• Neurogenic bladder

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah / Primary Childrens Medical Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Donald Null M.D.
• Organization: University of Utah

donald.null@imail.org

801.588-3865

Study Officials

• Donald .Null, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 5, 2008
• Study Start: January 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2009
• Last Updated: January 26, 2010
• Results First Posted: January 18, 2010

Record last verified: 2010-01

Locations

US (1)