Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children

Sponsor
Baxter Healthcare Corporation
Study ID
NCT00477152
Phase
PHASE4
Status
Completed

Conditions

  • Dehydration

Eligibility Criteria

Sex
ALL
Age
2 Months - 10 Years
Healthy Volunteers
Not accepted

Interventions

  • hyaluronidase (human recombinant)/rehydration fluid — DRUG
    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.

Study Details

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

Key Dates

Start date
Aug 31, 2007
Status verified
Nov 2011
Primary completion
Jun 30, 2008
Completion
Jun 30, 2008

Study Design

Enrollment
52 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

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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