Document Detail


Recombinant human hyaluronidase-enabled subcutaneous pediatric rehydration.
MedLine Citation:
PMID:  19805455     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Coburn H Allen; Lisa S Etzwiler; Melissa K Miller; George Maher; Sharon Mace; Mark A Hostetler; Sharon R Smith; Neil Reinhardt; Barry Hahn; George Harb;
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Publication Detail:
Type:  Clinical Trial, Phase IV; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2009-10-05
Journal Detail:
Title:  Pediatrics     Volume:  124     ISSN:  1098-4275     ISO Abbreviation:  Pediatrics     Publication Date:  2009 Nov 
Date Detail:
Created Date:  2009-12-02     Completed Date:  2009-12-31     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0376422     Medline TA:  Pediatrics     Country:  United States    
Other Details:
Languages:  eng     Pagination:  e858-67     Citation Subset:  AIM; IM    
Affiliation:
Section of Emergency Medicine,Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas 77030, USA. challen@texaschildrenshospital.org
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00477152
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MeSH Terms
Descriptor/Qualifier:
Child
Child, Preschool
Dehydration / therapy*
Female
Humans
Hyaluronoglucosaminidase / administration & dosage*,  adverse effects
Infant
Infusion Pumps
Infusions, Subcutaneous / adverse effects
Injections, Subcutaneous
Male
Recombinant Proteins / administration & dosage*,  adverse effects
Rehydration Solutions / administration & dosage*
Chemical
Reg. No./Substance:
0/Recombinant Proteins; 0/Rehydration Solutions; EC 3.2.1.35/Hyaluronoglucosaminidase
Investigator
Investigator/Affiliation:
Melissa Asgaonkar / ; Sarah Alander / ; Sudipa Barr / ; Troy Bush / ; Andrea T Cruz / ; M Denise Dowd / ; Kate Dutkiewicz / ; Donna Eckardt / ; Erin E Endom / ; Elysha Grauman / ; Jacquelyn Hoffman / ; Laura Kuensting / ; Joseph Nahlik / ; Binita Patel / ; Michael Petersen / ; Donald Reinke / ; Shirlee S Rusk / ; Maria Saccio / ; Beth L Schissel / ; Adam Silverman / ; Malinda Teague / ; Alison Tothy /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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