Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated … (NCT01120431) | Clinical Trial Compass
WithdrawnPhase 4
Efficacy and Time and Resources for Hylenex-facilitated SC Rehydration Versus ORT for Dehydrated Children in the Emergency Department (ED)
Stopped: Strategic business decision (not related to safety or efficacy concerns)
0Started 2010-05
Plain-language summary
The purpose is to evaluate the safety and efficacy as well as the time and resources needed in the ED setting to achieve rehydration in young pediatric subjects with mild to moderate dehydration using hylenex-facilitated SC rehydration versus oral rehydration therapy.
Who can participate
Age range
2 Months – 2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female and aged 2 months to 2 years
* Presenting to ED with mild or moderate dehydration
* Candidate for both parenteral and oral rehydration therapies
* Healthy, except for underlying etiology for dehydration
* Naive to ORT or having received attempted ORT at home for current occurrence of dehydration.
* Pre-dehydration body weight greater than 5th percentile for age
Exclusion Criteria:
* Severe dehydration
* Shock or a life-threatening situation
* Any condition precluding SC infusion or infusion site evaluation in all possible anatomical locations (upper back, anterior thighs, abdomen, other potential areas) for SC infusion
* Medical reason or condition precluding administration of ORT
* Indwelling IV catheter (except one intended only for laboratory sample collection) or anticipated need for IV therapy during the study
* Anticipated need for hospitalization(other than for rehydration)
* Known hypersensitivity to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
* Known hyponatremia, hypernatremia or hypokalemia
* Medical condition likely to interfere with ability to fully complete protocol-specified interventions and assessments, or likely to prolong need for medical attention beyond that required for rehydration
* Participation in an investigational drug or device study within 30 days before participation in this study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.