Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated Children in the Emergency Department (ED)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dehydration

Intervention / Treatment
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* Other: Oral rehydration fluid
* Drug: Isotonic hydration fluid and recombinant human hyaluronidase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female and aged 2 months to 2 years Presenting to ED with mild or moderate dehydration Candidate for both parenteral and oral rehydration therapies Healthy, except for underlying etiology for dehydration Naive to ORT or having received attempted ORT at home for current occurrence of dehydration. Pre-dehydration body weight greater than 5th percentile for age Exclusion Criteria: Severe dehydration Shock or a life-threatening situation Any condition precluding SC infusion or infusion site evaluation in all possible anatomical locations (upper back, anterior thighs, abdomen, other potential areas) for SC infusion Medical reason or condition precluding administration of ORT Indwelling IV catheter (except one intended only for laboratory sample collection) or anticipated need for IV therapy during the study Anticipated need for hospitalization(other than for rehydration) Known hypersensitivity to hyaluronidase or any other ingredient in the formulation of hylenex recombinant Known hyponatremia, hypernatremia or hypokalemia Medical condition likely to interfere with ability to fully complete protocol-specified interventions and assessments, or likely to prolong need for medical attention beyond that required for rehydration Participation in an investigational drug or device study within 30 days before participation in this study

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral rehydration therapy<br> | Other: Oral rehydration fluid<br>* Oral electrolyte solution or other clinically acceptable oral rehydration fluid, 5 to 10 mL of offered with encouragement every 5 to 10 minutes<br>* Other names: oral rehydration salts;|
| Experimental: hylenex-facilitated SC hydration<br> | Drug: Isotonic hydration fluid and recombinant human hyaluronidase<br>* Single subcutaneous dose of 150 U recombinant human hyaluronidase, followed by infusion pump-delivered subcutaneous isotonic hydration fluid<br>* Other names: 0.9% sodium chloride solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total resource utilization in the ED |  | 2 to 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful rehydration in the ED | Clinical judgement of adequate hydration, and either: 1) stable or increased body weight or 2) urine production | 2 to 8 hours | 
| Time to ED discharge |  | 2 to 8 hours | 
| Amount of rehydration fluid administered |  | 2 to 8 hours | 
| Global satisfaction and ease-of-use assessments by healthcare provider(s) and parent/caregiver |  | 2 to 8 hours | 
| Occurrence of infusion site pain or other local reactions |  | 2 to 8 hours | 
| Occurrence of other adverse events |  | 7 days | 
| Vital signs | Blood pressure, heart rate, respiratory rate, temperature | 2 to 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration, hyaluronan, rHuPH20, pediatric, ORT