Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children

Study Overview
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Brief Summary
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The aim of the study is to evaluate the safety, effectiveness and ease of use of subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes for the rehydration of pediatric patients with mild to moderate dehydration.

Detailed Description
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Pediatric patients (2 months to 10 years of age), presenting to the emergency department (ED) with mild to moderate dehydration and requiring parenteral rehydration, were treated with HYLENEX-augmented subcutaneous (SC) rehydration. An initial volume of 20 mL/kg of isotonic fluid was to be administered by continuous SC infusion over the first hour, and additional SC rehydration could be continued as clinically indicated. The preferred anatomic site for the SC infusion was the anterior thigh, unless there was an overriding preference for an alternate site. The duration of HYLENEX-augmented SC rehydration was to be a minimum of 1 hour and a maximum of 72 hours. The investigator or designee performed a clinical assessment of the subject's hydration status at baseline and at the end of SC infusion or at discharge from the ED. Other assessments of effectiveness and safety were made directly during the rehydration period and ED stay, and by telephone on Days 3 and 7 after discharge from the ED.

Official Title
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INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration (INFUSE-Pediatric Rehydration Study): Phase IV Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase (HYLENEX) for Infants and Children

Conditions
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Dehydration

Intervention / Treatment
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* Drug: hyaluronidase (human recombinant)/rehydration fluid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child, 2 months to 10 years of age Body weight less than 42 kg Presenting at emergency department with mild to moderate dehydration (Gorelick dehydration classification: presence of 1 to 6 [of possible 10] moderate or severe signs and symptoms) requiring parenteral rehydration Exclusion Criteria: In shock or life-threatening situation (other than dehydration) Severe dehydration Requires intravenous (IV) therapy for another indication Indwelling IV catheter (excepting one intended strictly for clinical laboratory sample collection) Already received rehydration therapy IV within prior 48 hours or substantial oral fluid immediately before enrollment Condition precluding subcutaneous injection or infusion site evaluation in anterior thigh or other elected infusion site Reason for hospital admission or extended emergency department stay other than dehydration Known hypersensitivity to hyaluronidase or another ingredient in HYLENEX Hyponatremia or hypernatremia Hypokalemia Medical condition likely to interfere with ability to fully complete study or have protocol-specified assessments Medical history, screening examination finding or historical clinical laboratory result precluding safe participation in study or which might adversely effect interpretation of study results Participated in study of any investigational drug or device within 30 days prior to this study

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 10 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HYLENEX-augmented subcutaneous (SC ) rehydration<br>Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours. | Drug: hyaluronidase (human recombinant)/rehydration fluid<br>* Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.<br>* Other names: HYLENEX recombinant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HYLENEX-facilitated Subcutaneous (SC) Rehydration Success | Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), and discharged to home | At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr) | 
| Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success | Successfully rehydrated (as medically judged by treating physician) without rescue therapy (ie, without receiving fluids via an alternate route), regardless of emergency department discharge destination | At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter |  | At end of placement of SC catheter | 
| Post-treatment Gorelick Dehydration Score | Score indicates the number of moderate-to-severe signs/symptoms of dehydration, based on assessment of each of the following 10 patient parameters: general condition, quality of radial pulse, quality of respiration, skin elasticity, eyes, tears, mucous membranes, urine output, heart rate and fingertip capillary refill time. Minimum score = 0; maximum score = 10. | At baseline and at either the end of subcutaneous infusion (mean duration = 5.73 ± 9.15 hr) or emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr) | 

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