Baxter Collaborating with Leading Institutions to Investigate Innovative Approach for Treating Dehydrated Children

Phase IV Trial to Evaluate a New Method That May Improve Patient Experience

 

DEERFIELD, Ill., June 16, 2009—Baxter International Inc. is working with leading U.S. hospitals and acute care centers 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.

 

“HYLENEX is good for patients and families because it lets us rehydrate children more easily and quickly with a procedure that can be less painful than an intravenous needle,” said Philip Spandorfer, MD, emergency medicine physician, Children's Healthcare of Atlanta at Scottish Rite.

 

An initial study of the use of HYLENEX for pediatric hydration already is complete, and data have been submitted for publication.

 

“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 the INFUSE-Pediatric Rehydration II Study

 

The multi-center study will consist of 148 evaluable patients, receiving fluids for rehydration by either subcutaneous administration with HYLENEX or IV administration to treat mild to moderate dehydration in the emergency room, inpatient pediatric unit, and/or outpatient urgent care facility. The primary endpoint for the study will be the total volume of fluid administered at a single infusion site, from the start to the cessation of fluid administration. The study also has several secondary endpoints, including (among others): time required to complete initial infusion; hydration status before and after administration based on standardized assessment; parent/guardian and healthcare provider satisfaction; number of personnel used for catheter/needle placement and maintenance; number of needle sticks required; and time from initiation of infusion to discharge. For more information on this trial, please visit: www.clinicaltrials.gov.

 

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.

 

About HYLENEX recombinant (hyaluronidase human injection)

 

HYLENEX is the first and only human recombinant hyaluronidase and is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for subcutaneous fluid administration; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. HYLENEX recombinant is a purified preparation of the enzyme, hyaluronidase. Hyaluronidase breaks down hyaluronic acid, a space-filling gel that exists in the subcutaneous (beneath the skin) tissue. HYLENEX has been approved by the U.S. Food and Drug Administration (FDA).  The safety and efficacy of HYLENEX has been demonstrated through clinical trial results in several patient populations.

 

Please see Important Safety Information for HYLENEX below.

 

Full Prescribing Information is available at http://www.hylenex.com/PDFS/PI.pdf.

 

About Baxter

 

Baxter International Inc. (NYSE:BAX), through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

 

Important Safety Information for HYLENEX

• Hypersensitivity to hyaluronidase or any other ingredient in the formulation is a contraindication to the use of this product.
• Discontinue HYLENEX recombinant (hyaluronidase human injection) if sensitization occurs.
• Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs.
• Hyaluronidase should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection.
• Hyaluronidase should not be used to reduce the swelling of bites or stings.
• Hyaluronidase should not be applied directly to the cornea.
• Hyaluronidase should not be used for intravenous injections because the enzyme is rapidly inactivated.
• Furosemide, the benzodiazepines and phenytoin have been found to be incompatible with hyaluronidase.
• The most frequently reported adverse experiences have been local injection site reactions.
• Hyaluronidase has been reported to enhance the adverse events associated with coadministered drug products.
• Allergic reactions (urticaria or angioedema) have been reported in less than 0.1% of patients receiving hyaluronidase.
• Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely.
• When hyaluronidase is added to a local anesthetic agent, it hastens the onset of analgesia and tends to reduce the swelling caused by local infiltration, but the wider spread of the local anesthetic solution increases its absorption; this shortens its duration of action and tends to increase the incidence of systemic reaction.
• Edema has been reported most frequently in association with subcutaneous fluid administration.
• The rate and volume of subcutaneous fluid administration should not exceed those employed for intravenous infusion. As with parenteral fluid therapy, use the same precautions for restoring fluid and electrolyte balance.
• During subcutaneous fluid administration, special care must be taken in pediatric patients to avoid over hydration by controlling the rate and total volume of the infusion.
• When solutions devoid of inorganic electrolytes are given subcutaneously, hypovolemia may occur.

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Baxter and Hylenex are trademarks of Baxter International Inc.

1. 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.

 

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For More Information

Media Contacts: Christy Hummel, (847) 948-4380 Erin Gardiner, (847) 948-4210