Conditions: Dehydration
Keywords: pediatric hylenex subcutaneous infusion hyaluronidase rHuPH20 recombinant human hyaluronidase
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 148
Healthy volunteers: no

Brief summary:
Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration in mildly to moderately dehydrated pediatric patients.

Detailed description:
This is a prospective, randomized (1:1 ratio), open-label, parallel group, multicenter, multi-national, study of SC versus IV fluid rehydration in mildly to moderately dehydrated pediatric patients treated in the Emergency Department (ED), inpatient pediatric unit, and/or outpatient urgent care facility. It is expected that up to 186 patients, in order to achieve 148 evaluable patients, will be randomized in a 1:1 ratio to receive isotonic fluid rehydration by either SC administration with hylenex (150 Units) or IV without hylenex.

Arms:
arm 1: Isotonic fluid rehydration by SC administration with hylenex (150 Units in 1 mL) arm 2: Isotonic fluid rehydration by IV

Interventions: intervention 1: recombinant human hyaluronidase
Intervention descriptions: intervention 1: 150 Units in 1 mL

Protocol document: