Clinical trial NCT00477152: Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dehydration
Keywords: dehydration
fluid therapy
pediatrics
emergency medicine
hyaluronoglucosaminidase
hyaluronidase
hypodermoclysis
clysis
subcutaneous hydration
subcutaneous rehydration
hyaluronan
rHuPH20
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Halozyme Therapeutics
name: PPD Development, LP
First posted: 2007-05-22
Enrollment: 52
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: HYLENEX-facilitated Subcutaneous (SC) Rehydration Success
timeFrame: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)
measure: Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success
timeFrame: At emergency department discharge (mean time to discharge = 7.03 ± 7.57 hr)
Secondary outcomes:
measure: Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter
timeFrame: At end of placement of SC catheter
measure: Post-treatment Gorelick Dehydration Score
timeFrame: 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)
Other outcomes:
Locations:
Study officials:
affiliation: Baxter Healthcare Corporation
name: George E Harb, MD
role: STUDY_DIRECTOR
References:
citation: Gorelick MH, Shaw KN, Murphy KO. Validity and reliability of clinical signs in the diagnosis of dehydration in children. Pediatrics. 1997 May;99(5):E6. doi: 10.1542/peds.99.5.e6.
citation: Allen CH, Etzwiler LS, Miller MK, Maher G, Mace S, Hostetler MA, Smith SR, Reinhardt N, Hahn B, Harb G; INcreased Flow Utilizing Subcutaneously-Enabled Pediatric Rehydration Study Collaborative Research Group. Recombinant human hyaluronidase-enabled subcutaneous pediatric rehydration. Pediatrics. 2009 Nov;124(5):e858-67. doi: 10.1542/peds.2008-3588. Epub 2009 Oct 5.