Dehydration Clinical Trial
Official title:
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
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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