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Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children (INFUSE-PR)

This study has been completed.
Sponsor:
Collaborators:
Halozyme Therapeutics
PPD
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00477152
First received: May 18, 2007
Last updated: November 22, 2011
Last verified: November 2011
History of Changes
Results First Received: September 12, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Dehydration
Intervention: Drug: hyaluronidase (human recombinant)/rehydration fluid

  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
Subjects recruited in emergency department after presenting with signs of mild to moderate dehydration

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HYLENEX-augmented Subcutaneous (SC) Rehydration Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.

Participant Flow:   Overall Study
    HYLENEX-augmented Subcutaneous (SC) Rehydration  
STARTED     52 [1]
COMPLETED     49 [2]
NOT COMPLETED     3  
Parent withdrew consent                 2  
Adverse Event                 1  
[1] One patient withdrawn prior to treatment, so not included in analyses.
[2] Two patients treated, but assessments incomplete. All available data included in analyses for these.



  Baseline Characteristics
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Reporting Groups
  Description
HYLENEX-augmented Subcutaneous (SC) Rehydration Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.

Baseline Measures
    HYLENEX-augmented Subcutaneous (SC) Rehydration  
Number of Participants  
[units: participants]
 		  51  
Age  
[units: years]
Mean ± Standard Deviation 		  1.91  ± 1.949  
Gender  
[units: participants]
 		 
Female     22  
Male     29  
Region of Enrollment  
[units: participants]
 		 
United States     51  
Age  
[units: participants]
 		 
>= 2 months to < 3 years     43  
>= 3 years to <= 10 years     8  
Gorelick Dehydration Score [1]
[units: Number of moderate/severe symptoms]
Mean ± Standard Deviation 		  3.5  ± 1.19  
[1] Score indicates the number of moderate-to-severe signs/symptoms of dehydration, based on assessment of each of the following ten patient parameters: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate and fingertip capillary refill time. Minimum score = 0; maximum score = 10. (Note: study inclusion criterion required a baseline score of 1 to 6.)



  Outcome Measures
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1.  Primary:   HYLENEX-facilitated Subcutaneous (SC) Rehydration Success   [ Time Frame: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr) ]
  Show Outcome Measure 1

2.  Primary:   Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success   [ Time Frame: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr) ]
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3.  Secondary:   Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter   [ Time Frame: At end of placement of SC catheter ]
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4.  Secondary:   Post-treatment Gorelick Dehydration Score   [ Time Frame: At baseline and at either the end of subcutaneous infusion (mean duration = 5.73 ± 9.15 hr) or emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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