At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 17 enrolled
Drug / intervention
Hylenexdrug
Likely dose
Hylenex 1mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase IV Randomized Study of Hylenex or Standard IV Hydration in the Pediatric Population With Moderate Dehydration
In Brief
A Phase 4 clinical trial evaluating Hylenex for Dehydration and 2 related conditions. Completed, enrolled 17 participants across 1 site.
Detailed Summary
The purpose of this study is to non-invasively study the reflective changes in cardiac output as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric patients using sub-q rehydration using Hylenex augmented subcutaneous infusion of fluids and electrolytes compared to intravenous methods.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDehydration, Cardiac Output, Pediatrics
CountriesUnited States
CollaboratorsBaxter Healthcare Corporation
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedJun 2010
Primary CompletionNov 2011
TodayJul 2026
First PostedJun 8, 2010
Enrollment StartFeb 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.1 years ago
Interventions
Hylenexdrug
1ml subcutaneous with initiation of intravenous fluids then every 24 hrs with a maximum dose of 3 injections in 72 hours