Subcutaneous Rehydration Compared to Intravenous Rehydration

Subcutaneous Rehydration With Hylenex Compared to Intravenous Rehydration in Infants and Young Children With Mild to Moderate Dehydration

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

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.

Inclusion Criteria:

• Children of either gender from one month to ≤10 years of age.
• Patients with mild or moderate dehydration
• Healthy child except for the underlying etiology for dehydration
• Pre-dehydration body weight ≥ 5th percentile for age
• Parents or legal guardian(s) available to provide informed consent.

Exclusion Criteria:

• Severe dehydration
• Shock or life-threatening situation (life expectancy < 10 days).
• Requirement for IV access for any indication other than for treatment of dehydration.
• Indwelling IV catheter, except for one intended only for collection of clinical laboratory specimens.
• Any condition precluding SC infusion or infusion site evaluation
• Any reason (prior to study enrollment) for a hospital admission or an extended stay in the ED for other than dehydration.
• Known hypersensitivity to hyaluronidase or hylenex.
• Known hyponatremia (< 130 milliequivalents per liter [mEq/L]) or hypernatremia (> 155 mEq/L).
• Known hypokalemia (< 3.0 mEq/L).
• Any medical condition likely to interfere with the patient's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the patient's need for medical attention beyond that required for treatment of dehydration.
• Participation in an investigational drug or device study within 30 days prior to enrollment in this study.