Phase 4
N=52
Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children
Dehydration
Bottom Line
View on ClinicalTrials.gov: NCT00477152 ↗Enrolled (actual)
52
Serious AEs
2.0%
Results posted
Nov 2011
Primary outcome: Primary: HYLENEX-facilitated Subcutaneous (SC) Rehydration Success — 43 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- hyaluronidase (human recombinant)/rehydration fluid (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Baxter Healthcare Corporation
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HYLENEX-facilitated Subcutaneous (SC) Rehydration Success |
43 | — |
| PRIMARY Modified HYLENEX-facilitated Subcutaneous (SC) Rehydration Success |
48 | — |
| SECONDARY Number of Attempts Needed to Successfully Place Subcutaneous (SC) Catheter |
46; 5 | — |
| SECONDARY Post-treatment Gorelick Dehydration Score |
0.5; -3.0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00477152). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.