Published online October 5, 2009
PEDIATRICS Vol. 124 No. 5 November 2009, pp. e858-e867 (doi:10.1542/peds.2008-3588)
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ARTICLE

Recombinant Human Hyaluronidase-Enabled Subcutaneous Pediatric Rehydration

Coburn H. Allen, MDa,b, Lisa S. Etzwiler, MDc, Melissa K. Miller, MDd, George Maher, DOe, Sharon Mace, MDf, Mark A. Hostetler, MD, MPHg, Sharon R. Smith, MDh, Neil Reinhardt, MDi, Barry Hahn, MDj, George Harb, MDk for the INcreased Flow Utilizing Subcutaneously-Enabled-(INFUSE) Pediatric Rehydration Study Collaborative Research Group

Sections of a Emergency Medicine
b Infectious Diseases, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas
c Department of Emergency Medicine, St John's Mercy Children's Hospital, St Louis, Missouri
d Emergency Medical Services, Children's Mercy Hospital, Kansas City, Missouri
e Pediatric Hospitalist Service, Memorial Children's Hospital, South Bend, Indiana
f Department of Emergency Medicine, Cleveland Clinic, Cleveland, Ohio
g Department of Pediatrics, University of Chicago, Chicago, Illinois
h Division of Emergency Medicine, Department of Pediatrics, Connecticut Children's Medical Center, Hartford, Connecticut
i Pediatric Emergency Department, Tampa General Hospital, Tampa, Florida
j Department of Emergency Medicine, Staten Island University Hospital, Staten Island, New York
k Department of Medication Delivery, Baxter Healthcare, Deerfield, Illinois

OBJECTIVES: The Increased Flow Utilizing Subcutaneously-Enabled (INFUSE)-Pediatric Rehydration Study was designed to assess efficacy, safety, and clinical utility of recombinant human hyaluronidase (rHuPH20)-facilitated subcutaneous rehydration in children 2 months to 10 years of age.

METHODS: Patients with mild/moderate dehydration requiring parenteral treatment in US emergency departments were eligible for this phase IV, multicenter, single-arm study. They received subcutaneous injection of 1 mL rHuPH20 (150 U), followed by subcutaneous infusion of 20 mL/kg isotonic fluid over the first hour. Subcutaneous rehydration was continued as needed for up to 72 hours. Rehydration was deemed successful if it was attributed by the investigator primarily to subcutaneous fluid infusion and the child was discharged without requiring an alternative method of rehydration.

RESULTS: Efficacy was evaluated in 51 patients (mean age: 1.9 years; mean weight: 11.2 kg). Initial subcutaneous catheter placement was achieved with 1 attempt for 46/51 (90.2%) of patients. Rehydration was successful for 43/51 (84.3%) of patients. Five patients (9.8%) were hospitalized but deemed to be rehydrated primarily through subcutaneous therapy, for a total of 48/51 (94.1%) of patients. No treatment-related systemic adverse events were reported, but 1 serious adverse event occurred (cellulitis at infusion site). Investigators found the procedure easy to perform for 96% of patients (49/51 patients), and 90% of parents (43/48 parents) were satisfied or very satisfied.

CONCLUSIONS: rHuPH20-facilitated subcutaneous hydration seems to be safe and effective for young children with mild/moderate dehydration. Subcutaneous access is achieved easily, and the procedure is well accepted by clinicians and parents.


Key Words: rehydration • dehydration • hyaluronidase • pediatric • subcutaneous

Abbreviations: ORT—oral rehydration therapy • rHuPH20—recombinant human hyaluronidase • ED—emergency department • AE—adverse event


Accepted Jun 4, 2009.


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eLetters:

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Controlled trials needed
Dan Sontheimer, et al.
Pediatrics Online, 9 Oct 2009 [Full text]