Status:
COMPLETED
Subcutaneous Rehydration Compared to Intravenous Rehydration
Lead Sponsor:
Halozyme Therapeutics
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Dehydration
Eligibility:
All Genders
30-10 years
Phase:
PHASE4
Brief Summary
Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration in mildly to moderately dehydrated pediatric patients.
Detailed Description
This is a prospective, randomized (1:1 ratio), open-label, parallel group, multicenter, multi-national, study of SC versus IV fluid rehydration in mildly to moderately dehydrated pediatric patients tr...
Eligibility Criteria
Inclusion
- Children of either gender from one month to ≤10 years of age.
- Patients with mild or moderate dehydration
- Healthy child except for the underlying etiology for dehydration
- Pre-dehydration body weight ≥ 5th percentile for age
- Parents or legal guardian(s) available to provide informed consent.
Exclusion
- Severe dehydration
- Shock or life-threatening situation (life expectancy \< 10 days).
- Requirement for IV access for any indication other than for treatment of dehydration.
- Indwelling IV catheter, except for one intended only for collection of clinical laboratory specimens.
- Any condition precluding SC infusion or infusion site evaluation
- Any reason (prior to study enrollment) for a hospital admission or an extended stay in the ED for other than dehydration.
- Known hypersensitivity to hyaluronidase or hylenex.
- Known hyponatremia (\< 130 milliequivalents per liter \[mEq/L\]) or hypernatremia (\> 155 mEq/L).
- Known hypokalemia (\< 3.0 mEq/L).
- Any medical condition likely to interfere with the patient's ability to fully complete all protocol-specified interventions, the ability to undergo all protocol-specified assessments, or likely to prolong the patient's need for medical attention beyond that required for treatment of dehydration.
- Participation in an investigational drug or device study within 30 days prior to enrollment in this study.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT00773175
Start Date
October 1 2008
End Date
December 1 2009
Last Update
November 7 2018
Active Locations (25)
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1
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
2
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
3
Tampa General Hospital Children's Medical Center
Tampa, Florida, United States, 33606
4
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322