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Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children (INFUSE-PR)
This study has been completed.
Study NCT00477152   Information provided by Baxter Healthcare Corporation
First Received: May 18, 2007   Last Updated: September 25, 2008   History of Changes

May 18, 2007
September 25, 2008
August 2007
June 2008   (final data collection date for primary outcome measure)
Rehydration success rate (effectiveness) in children treated with HYLENEX-augmented fluid infusion [ Time Frame: 1-3 days ] [ Designated as safety issue: No ]
Rehydration success rate (effectiveness) in children treated with HYLENEX-augmented fluid infusion
Complete list of historical versions of study NCT00477152 on ClinicalTrials.gov Archive Site
Safety of HYLENEX-augmented fluid infusion in children [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Safety of HYLENEX-augmented fluid infusion in children
 
Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children
INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration (INFUSE-Pediatric Rehydration Study): Phase IV Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase (HYLENEX) for Infants and Children

The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous rehydration using HYLENEX-augmented subcutaneous infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.

 
Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Dehydration
Drug: hyaluronidase (human recombinant)/rehydration fluid
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
51
June 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Child, 2 months to 10 years of age
  • Body weight less than 42 kg
  • Presenting at emergency department with mild to moderate dehydration requiring parenteral rehydration

Exclusion Criteria:

  • In shock or life-threatening situation (other than dehydration)
  • Severe dehydration
  • Requires IV therapy for another indication
  • Indwelling IV catheter (excepting one intended strictly for clinical laboratory sample collection)
  • Already received rehydration therapy IV within prior 48 hours or substantial oral fluid immediately before enrollment
  • Condition precluding subcutaneous injection or infusion site evaluation in anterior thigh or other elected infusion site
  • Reason for hospital admission or extended ED stay other than dehydration
  • Known hypersensitivity to hyaluronidase or another ingredient in HYLENEX
  • Hyponatremia or hypernatremia
  • Hypokalemia
  • Medical condition likely to interfere with ability to fully complete study or have protocol-specified assessments
  • Medical history, screening examination finding or historical clinical laboratory result precluding safe participation in study or which might adversely effect interpretation of study results
  • Participated in study of any investigational drug or device within 30 days prior to this study
Both
2 Months to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00477152
George E. Harb, MD, Baxter Healthcare Corporation
1838-003
Baxter Healthcare Corporation
  • Halozyme Therapeutics
  • PPD
Study Director: George E Harb, MD Baxter Healthcare Corporation
Baxter Healthcare Corporation
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP