Q: What alternative approaches to rehydration is Tampa General Hospital currently investigating?
A:Baxter International Inc. is working with leading U.S. hospitals and acute care centers, including Tampa General Hospital, to determine if an alternative approach to rehydration, facilitated by HYLENEX recombinant (hyaluronidase human injection), will improve the treatment experience for infants and young children suffering from mild to moderate dehydration.
When parents are unable to give their children fluids orally, often because of vomiting, their pediatrician may send them to the emergency room to receive intravenous (IV) fluids or fluids through the veins. This approach can take multiple needle sticks and may require several caregivers, making for a traumatic and time-consuming event for patients, parents and clinicians. HYLENEX facilitated subcutaneous rehydration is an alternative to IV administration. HYLENEX allows fluids to be administered under the skin rather than through a vein, especially when fluid replacement is all that a child needs.
HYLENEX temporarily makes the tissue beneath the skin more permeable (capable of being passed through) and able to absorb fluid, allowing fluids to be absorbed more readily into the blood vessels. Once HYLENEX has been given, fluids can be administered subcutaneously through the same catheter. The Increased Flow Utilizing Subcutaneously-Enabled (INFUSE) Pediatric Rehydration II study is being conducted to investigate whether HYLENEX facilitated subcutaneous administration of fluids can be given safely and effectively to infants and young children with mild to moderate dehydration in amounts no less than that delivered by IV administration.
Several research sites nationwide are participating in the phase IV trial, including:
• Children’s Memorial Hospital – Chicago
• Children’s Healthcare of Atlanta at Scottish Rite
• Tampa General Hospital Children’s Medical Center
• Children’s Medical Center of Dallas
• Baylor College of Medicine – Houston
• Staten Island University Hospital
• Memorial Hospital & Health System – South Bend, Ind.
Three of these institutions are ranked in the top 30 on the 2008 U.S. News & World Report list of best children’s hospitals for general pediatrics. “We have seen promising data from the initial trial of use in mild to moderate dehydration, and are conducting this new trial to further validate the use of HYLENEX for the pediatric population,” said George Harb, MD, MPH, Baxter’s therapeutic area leader for HYLENEX. “HYLENEX offers an alternative to current rehydration therapies and may make a sometimes difficult situation easier for dehydrated children, their families and clinicians, and provide for a more comfortable patient experience.”
Baxter plans to launch HYLENEX for the pediatric population later this year.
About Dehydration
Dehydration can occur in anyone of any age, but can be especially concerning for infants and young children. In children, dehydration often occurs as a result of an illness, especially when a child is losing more fluids than they are taking in (e.g., in the case of vomiting and/or diarrhea).
One of the most common causes of dehydration in children in the U.S. is acute gastroenteritis, which is responsible for more than 1.5 million outpatient visits, 200,000 hospital stays, and approximately 300 deaths per year.1 Delay in treatment can lead to a greater degree of dehydration. It is important to recognize the signs and symptoms of dehydration and seek medical attention when necessary to avoid complications.
Full Prescribing Information is available at http://www.hylenex.com/PDFS/PI.pdf
King C, Glass R, Bresee J, et al. Managing Acute Gastroenteritis Among Children. Atlanta, GA: Department of Health and Human Services, Centers for Disease Control and Prevention; 2003. Nov. 21.
