Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated Children in the Emergency Department (ED)

The INcreased Flow Utilizing Subcutaneously-Enabled Time-Motion (INFUSE-TM) Study: A Randomized, Open-label, Parallel-group, Multicenter Study Evaluating Efficacy and Time and Resources in the Emergency Department for Hylenex-facilitated Subcutaneous Rehydration Versus Oral Rehydration Therapy in Pediatric Patients With Mild to Moderate Dehydration

The purpose is to evaluate the safety and efficacy as well as the time and resources needed in the ED setting to achieve rehydration in young pediatric subjects with mild to moderate dehydration using hylenex-facilitated SC rehydration versus oral rehydration therapy.

Inclusion Criteria:

• Male or female and aged 2 months to 2 years
• Presenting to ED with mild or moderate dehydration
• Candidate for both parenteral and oral rehydration therapies
• Healthy, except for underlying etiology for dehydration
• Naive to ORT or having received attempted ORT at home for current occurrence of dehydration.
• Pre-dehydration body weight greater than 5th percentile for age

Exclusion Criteria:

• Severe dehydration
• Shock or a life-threatening situation
• Any condition precluding SC infusion or infusion site evaluation in all possible anatomical locations (upper back, anterior thighs, abdomen, other potential areas) for SC infusion
• Medical reason or condition precluding administration of ORT
• Indwelling IV catheter (except one intended only for laboratory sample collection) or anticipated need for IV therapy during the study
• Anticipated need for hospitalization(other than for rehydration)
• Known hypersensitivity to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
• Known hyponatremia, hypernatremia or hypokalemia
• Medical condition likely to interfere with ability to fully complete protocol-specified interventions and assessments, or likely to prolong need for medical attention beyond that required for rehydration
• Participation in an investigational drug or device study within 30 days before participation in this study