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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Oral electrolyte solution or other clinically acceptable oral rehydration fluid, 5 to 10 mL of offered with encouragement every 5 to 10 minutes
Single subcutaneous dose of 150 U recombinant human hyaluronidase, followed by infusion pump-delivered subcutaneous isotonic hydration fluid
Total resource utilization in the ED
Time frame: 2 to 8 hours
Rate of successful rehydration in the ED
Clinical judgement of adequate hydration, and either: 1) stable or increased body weight or 2) urine production
Time frame: 2 to 8 hours
Time to ED discharge
Time frame: 2 to 8 hours
Amount of rehydration fluid administered
Time frame: 2 to 8 hours
Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver
Time frame: 2 to 8 hours
Occurrence of infusion site pain or other local reactions
Time frame: 2 to 8 hours
Occurrence of other adverse events
Time frame: 7 days
Vital signs
Blood pressure, heart rate, respiratory rate, temperature
Time frame: 2 to 8 hours
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