NCT00773175

Subcutaneous Rehydration Compared to Intravenous Rehydration

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Halozyme Therapeutics · Industry
• Sex: All
• Age: 30 Days – 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dehydration

Interventions

Type	Name	Description
DRUG	recombinant human hyaluronidase	150 Units in 1 mL

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2008-10-16
• Last updated: 2018-11-07
• Results posted: 2018-11-07

Locations

25 sites across 1 country: United States