NCT01120431

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 2 Months – 2 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dehydration

Interventions

Type	Name	Description
OTHER	Oral rehydration fluid	Oral electrolyte solution or other clinically acceptable oral rehydration fluid, 5 to 10 mL of offered with encouragement every 5 to 10 minutes
DRUG	Isotonic hydration fluid and recombinant human hyaluronidase	Single subcutaneous dose of 150 U recombinant human hyaluronidase, followed by infusion pump-delivered subcutaneous isotonic hydration fluid

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-05-11
• Last updated: 2017-05-08